Product Code: KKX
FDA class 2
21 CFR 878.4370
Drape, Surgical
General, Plastic Surgery
A Surgical Drape is a sterile barrier device used during surgical procedures to create and maintain an aseptic field around the operative site, reducing the risk of microbial contamination and surgical site infection. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The product code is KKX, the regulation is 21 CFR 878.4370, and the medical specialty is General and Plastic Surgery. This device is eligible for third-party review.
510(k)s
450
FEI Numbers
219
Registration Numbers
219
Unique Applicants
254
Years Active
47
Basic Information
- Product Code
- KKX
- Device Class
- FDA class 2
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 450 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K230645 | BeneHold Surgical Incise Drape with CHG antimicrobial II | Oct 25, 2023 | Substantially Equivalent | Avery Dennison Medical Ltd. |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) | May 18, 2023 | Substantially Equivalent | 3M Company |
| K202208 | BeneHold Surgical Incise Drape with CHG antimicrobial | Jul 30, 2021 | Substantially Equivalent | Avery Dennison Belgie BVBA |
| K200238 | ControlRad Sterile Cover | Apr 26, 2020 | Substantially Equivalent | ControlRad, Inc |
| K163556 | MediClear PreOp | Sep 14, 2017 | Substantially Equivalent | COVALON TECHNOLOGIES, INC. |
| K133080 | Plus Surgical Drapes (EO Sterilized), PMDB-XXX | Jun 24, 2015 | Substantially Equivalent | FOSHAN NANHAI PLUS MEDICAL CO., LTD. |
| K141324 | HONGYU DISPOSABLE SURGICAL DRAPES | Apr 14, 2015 | Substantially Equivalent | WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD |
| K140195 | SURGICAL DRAPE | Sep 10, 2014 | Substantially Equivalent | GRIFFITH-LUCAS LLC |
| K140330 | 3M STERI-DRAPE FABRIC SURGICAL DRAPES | Aug 18, 2014 | Substantially Equivalent | 3M HEALTH CARE |
| K141438 | WHITNEY MEDICAL SOLUTIONS ESHIELD | Aug 14, 2014 | Substantially Equivalent | WHITNEY MEDICAL SOLUTIONS |
| K140250 | 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE | Jul 25, 2014 | Substantially Equivalent | 3M HEALTH CARE |
| K140064 | SURGISLEEVE WOUND PROTECTOR | Mar 12, 2014 | Substantially Equivalent | COVIDIEN |
| K131571 | AVD RIGHT RADIAL DRAPE | Jan 31, 2014 | Substantially Equivalent | ADVANCED VASCULAR DYNAMICS |
| K130404 | TIBURON SURGICAL DRAPE | Jul 05, 2013 | Substantially Equivalent | CARDINAL HEALTH 200, LLC |
| K121436 | DAS MEDICAL EQUIPMENT DRAPES | Jun 06, 2013 | Substantially Equivalent | DAS MEDICAL, LLC |
| K121919 | SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV | Feb 14, 2013 | Substantially Equivalent | EXACT MEDICAL MANUFACTURING, INC |
| K122000 | HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER | Dec 12, 2012 | Substantially Equivalent | CHANGZHOU HOLYMED PRODUCTS CO LTD |
| K112378 | COBES SURGICAL DRAPE | May 08, 2012 | Substantially Equivalent | COBES INDUSTRIES CO., LTD. |
| K111458 | GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS | Dec 01, 2011 | Substantially Equivalent | GRI MEDICAL & ELECTRONIC TECHNOLOGY CO., LTD. |
| K112136 | TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE | Sep 29, 2011 | Substantially Equivalent | KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD. |
| K102861 | SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE) | Jan 13, 2011 | Substantially Equivalent | A PLUS INTERNATIONAL, INC. |
| K101350 | RADSCAN EQUIPMENT SLICKER | Jan 04, 2011 | Substantially Equivalent | RADSCAN MEDICAL EQUIPMENT, INC. |
| K094016 | NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATION INFUSED (R) OR TOWEL (WITH BINDING) MODEL HUCKCR17X27MH, H | Nov 19, 2010 | Substantially Equivalent | HINSON AND HALE MEDICAL TECHNOLOGIES, INC |
| K102666 | KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM | Nov 09, 2010 | Substantially Equivalent | KIMBERLY-CLARK CORP. |
| K100991 | IMC SURGICAL DRAPE | Oct 05, 2010 | Substantially Equivalent | INTERNATIONAL MEDSURG CONNECTION |
| K101598 | EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) | Oct 04, 2010 | Substantially Equivalent | EXACT MEDICAL MANUFACTURING, INC |
| K101689 | EMM EQUIPMENT COVER-POLYTHYLENE | Sep 20, 2010 | Substantially Equivalent | EXACT MEDICAL MANUFACTURING, INC |
| K101688 | EMM SURGICAL DRAPE-SPUNLACE W/PE SIDES, MODEL 13-004 | Sep 20, 2010 | Substantially Equivalent | EXACT MEDICAL MANUFACTURING, INC |
| K093909 | BUSSE SURGICAL DRAPES IV | May 06, 2010 | Substantially Equivalent | BUSSE HOSPITAL DISPOSABLES, INC. |
| K100208 | IMC SURGICAL DRAPE | Apr 20, 2010 | Substantially Equivalent | INTERNATIONAL MEDSURG CONNECTION |
| K092212 | BUSSE SURGICAL DRAPES III | Oct 09, 2009 | Substantially Equivalent | BUSSE HOSPITAL DISPOSABLES, INC. |
| K091343 | MRI NEURO DRAPE | Sep 22, 2009 | Substantially Equivalent | SURGIVISION, INC. |
| K083234 | KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100 | Mar 25, 2009 | Substantially Equivalent | KIMBERLY-CLARK CORP. |
| K083320 | DUKAL SURGICAL DRAPE; FENESTRATED DUKAL SURGICAL DRAPE | Mar 06, 2009 | Substantially Equivalent | DUKAL CORP. |
| K083424 | BUSSE SURGICAL DRAPE | Feb 26, 2009 | Substantially Equivalent | BUSSE HOSIPITAL DISPOSABLES |
| K082297 | BUSSE SURGICAL DRAPE | Dec 09, 2008 | Substantially Equivalent | BUSSE HOSPITAL DISPOSABLES, INC. |
| K080796 | SRI LP DRAPE | Nov 17, 2008 | Substantially Equivalent | SRI/SURGICAL EXPRESS |
| K080629 | PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS | Oct 20, 2008 | Substantially Equivalent | PROMEDICAL PRODUCTS CO., LTD. |
| K081476 | SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE | Aug 08, 2008 | Substantially Equivalent | SURGICAL CONCEPT DESIGNS |
| K080341 | ENDODRAPE(TM) | Jul 21, 2008 | Substantially Equivalent | VORTEK SURGICAL, LLC |
| K071491 | ARROW INTERNATIONAL, INC., SURGICAL DRAPES | Oct 10, 2007 | Substantially Equivalent | ARROW INTL., INC. |
| K070432 | GENERAL SURGERY DRAPES | Sep 24, 2007 | Substantially Equivalent | WELMED INC. |
| K070406 | ENDODRAPE | Jul 30, 2007 | Substantially Equivalent | VORTEK SURGICAL, LLC |
| K062480 | JOYKEY SURGICAL DRAPES (STERILE) | Mar 05, 2007 | Substantially Equivalent | JOYKEY INDUSTRYIAL LTD. |
| K061422 | SURGICAL DRAPES | Sep 25, 2006 | Substantially Equivalent | AUSTIN MEDICAL, INC. |
| K061762 | TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N | Aug 01, 2006 | Substantially Equivalent | CARDINAL HEALTH, INC. |
| K052668 | OR SPECIFIC BIG CASE BACK TABLE COVER | Jul 24, 2006 | Substantially Equivalent | OR SPECIFIC, INC. |
| K060200 | MICROTEK MEDICAL WARMING DRAPE | May 31, 2006 | Substantially Equivalent | MICROTEK MEDICAL, INC. |
| K053495 | EQUIPMENT SLUSH DRAPE | Mar 16, 2006 | Substantially Equivalent | ADVANCE MEDICAL DESIGNS, INC. |
| K052833 | GORE-TEX NON-STERILE SURGICAL GOWNS | Feb 15, 2006 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K052395 | STERILE EQUIPMENT COVERS | Dec 01, 2005 | Substantially Equivalent | VOLCANO CORPORATION |
| K052169 | IMC SURGICAL DRAPES | Nov 17, 2005 | Substantially Equivalent | INTERNATIONAL MEDSURG CONNECTION, INC. |
| K043015 | 3L SURGICAL DRAPES | Aug 15, 2005 | Substantially Equivalent | 3L MEDICAL PRODUCTS CO., LTD. |
| K051625 | BARRIER SURGICAL DRAPES | Jul 14, 2005 | Substantially Equivalent | MOLNLYCKE HEALTH CARE, INC. |
| K050538 | IMC DRAPES | Jun 07, 2005 | Substantially Equivalent | INTL. MEDSURG CONNECTION, INC. |
| K050322 | MICROTEK EQUIPMENT DRAPES | May 17, 2005 | Substantially Equivalent | MICROTEK MEDICAL, INC. |
| K042977 | LASIK EYE DRAPE | May 10, 2005 | Substantially Equivalent | ODYSSEY MEDICAL, INC. |
| K050508 | HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES | Apr 27, 2005 | Substantially Equivalent | HAYWOOD VOCATIONAL OPPORTUNITIES |
| K042526 | DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX | Apr 25, 2005 | Substantially Equivalent | MEDICAL ACTION INDUSTRIES, INC. |
| K032666 | MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES | Mar 16, 2005 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K042893 | UNDER BUTTOCKS DRAPE | Mar 11, 2005 | Substantially Equivalent | INTERNATIONAL MEDSURG CONNECTION, INC. |
| K041224 | FOOTHILLS SURGICAL DRAPES | Feb 03, 2005 | Substantially Equivalent | FOOTHILLS INDUSTRIES, INC. |
| K042131 | PROMEDICAL SURGICAL DRAPES | Dec 10, 2004 | Substantially Equivalent | PROMEDICAL PRODUCTS CO., LTD. |
| K042137 | PROMEDICAL SURGICAL MAYO STAND COVERS, BAND BAGS, TABLE COVERS AND EQUIPMENT COVERS | Oct 05, 2004 | Substantially Equivalent | PROMEDICAL PRODUCTS CO., LTD. |
| K041846 | SABRESOURCE DRAPE | Aug 26, 2004 | Substantially Equivalent | MINRAD, INC. |
| K041077 | IMALUX OCT PROBE GUIDE | Jun 25, 2004 | Substantially Equivalent | IMALUX CORPORATION |
| K031889 | ALEXIS WOUND RETRACTOR | Sep 22, 2003 | Substantially Equivalent | APPLIED MEDICAL RESOURCES CORP. |
| K031287 | STERI-DRAPE SURGICAL DRAPES | Sep 10, 2003 | Substantially Equivalent | 3M COMPANY |
| K030908 | DEROYAL SURGICAL DRAPES BACKTABLE COVER | Aug 11, 2003 | Substantially Equivalent | DEROYAL |
| K031131 | KLINIDRAPE SURGICAL DRAPES | Jun 10, 2003 | Substantially Equivalent | MOLNLYCKE HEALTH CARE |
| K031362 | LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS | May 30, 2003 | Substantially Equivalent | LAC MAC, LTD. |
| K030365 | DEROYAL DRAPES, STERILE, NON-STERILE | Apr 29, 2003 | Substantially Equivalent | DEROYAL INDUSTRIES, INC. |
| K023419 | TRILAMINATE DRAPES/TIBURON | Feb 11, 2003 | Substantially Equivalent | ALLEGIANCE HEALTHCARE CORP. |
| K023117 | PRIMAGARD SURGICAL GOWNS | Nov 08, 2002 | Substantially Equivalent | PRIMELINE MEDICAL PRODUCTS, INC. |
| K022868 | PRIMAGARD SURGICAL EQUIPMENT DRAPES | Nov 08, 2002 | Substantially Equivalent | PRIMELINE MEDICAL PRODUCTS, INC. |
| K023425 | DRAPES WITH ABSORBENT REINFORCEMENT | Nov 06, 2002 | Substantially Equivalent | ALLEGIANCE HEALTHCARE CORP. |
| K023432 | MEDLINE ASEP PLUS SURGICAL DRAPES | Nov 04, 2002 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K021864 | PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119, PM1-0142) | Sep 23, 2002 | Substantially Equivalent | PRIMELINE MEDICAL PRODUCTS, INC. |
| K020581 | COLOSHIELD COLONOSCOPY DRAPE MODEL E2000 | Sep 18, 2002 | Substantially Equivalent | MEDICAL CONCEPTS DEVELOPMENT, INC. |
| K013958 | INDUS TEXTILES TOWEL-STERILE AND NON-STERILE | Aug 19, 2002 | Substantially Equivalent | INDUS TEXTILES, INC. |
| K020393 | MASTER & FRANK SURGICAL DRAPES (STERILE) | May 03, 2002 | Substantially Equivalent | MASTER & FRANK ENTERPRSES CO.LTD. |
| K020435 | WOUND PROTECTOR/RETRACTOR | Apr 15, 2002 | Substantially Equivalent | APPLIED MEDICAL RESOURCES CORP. |
| K012957 | TOWEL DRAPE, MODELS 4409, 4410 | Mar 06, 2002 | Substantially Equivalent | DYNAREX CORP. |
| K012237 | MERTEX-PLUS REUSABLE SURGICAL DRAPE | Oct 15, 2001 | Substantially Equivalent | MERCAN AB |
| K012807 | MODIFICATION TO: COMPEL SURGICAL DRAPES | Oct 11, 2001 | Substantially Equivalent | STANDARD TEXTILE CO., INC. |
| K012168 | ADVANCE MEDICAL DESIGNS FLUID POUCH | Sep 18, 2001 | Substantially Equivalent | ADVANCE MEDICAL DESIGNS, INC. |
| K011422 | SURGICAL DRAPES | Jul 10, 2001 | Substantially Equivalent | ADVANCE MEDICAL DESIGNS, INC. |
| K010711 | ECOTRACT ADJUSTABLE WOUND PROTECTOR/RETRACTOR | May 22, 2001 | Substantially Equivalent | ADVANCED SURGICAL CONCEPTS (ASC) |
| K000442 | ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX | Apr 24, 2001 | Substantially Equivalent | MEDICAL CONCEPTS DEVELOPMENT, INC. |
| K010572 | BD VISIDRAPE OPHTHALMIC DRAPES; BD VISIFLEX INCISE DRAPE | Mar 12, 2001 | Substantially Equivalent | BECTON DICKINSON AND CO. |
| K003670 | PATIENT DRAPE, SURGICAL | Jan 26, 2001 | Substantially Equivalent | ADVANCE MEDICAL DESIGNS, INC. |
| K002691 | COM-MED O.R. TOWEL - NON-STERILE, BLUE, GREEN, WHITE | Dec 08, 2000 | Substantially Equivalent | COM-MED INTERNATIONAL, INC. |
| K002702 | NEUROTOLOGY DRAPE, MODEL TBD | Oct 26, 2000 | Substantially Equivalent | GYRUS ENT L.L.C. |
| K002508 | EQUIPMENT DRAPES | Sep 01, 2000 | Substantially Equivalent | ALLEGIANCE HEALTHCARE CORP. |
| K001858 | OPERATING ROOM TOWEL, STERILE, COLORS BLUE OR WHITE | Aug 17, 2000 | Substantially Equivalent | CHINA NANTONG GUANGDA TEXTILE CO., LTD. |
| K002419 | SURGICAL DRAPES | Aug 15, 2000 | Substantially Equivalent | ALLEGIANCE HEALTHCARE COPORATION |
| K001994 | EEI SLUSH PAN DRAPE | Aug 04, 2000 | Substantially Equivalent | EAGLE ENDOSCOPIC, INC. |
| K001667 | RESOLVE SURGICAL O.R. TOWELS | Jun 23, 2000 | Substantially Equivalent | ALLEGIANCE HEALTHCARE CORP. |
| K000906 | KLINIDRAPE SURGICAL DRAPES | Jun 23, 2000 | Substantially Equivalent | MOLNLYCKE HEALTH CARE, INC. |
| K994199 | VARIOUS STERILE AND NON-STERILE SURGICAL DRAPES, (I.E., DISPOSABLES MINOR PROCEDURE DRAPES, LARGE APERTURE DRAPES, ABSOR | Jun 09, 2000 | Substantially Equivalent | CUSTOM MEDICAL PRODUCTS, INC. |
| K000417 | CONVERTORS EQUIPMENT DRAPES | Mar 17, 2000 | Substantially Equivalent | ALLEGIANCE HEALTHCARE CORP. |
| K994211 | ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285 | Feb 04, 2000 | Substantially Equivalent | DENTSPLY INTL. |
| K993795 | CONVERTORS SURGICAL DRAPES | Jan 12, 2000 | Substantially Equivalent | ALLEGIANCE HEALTHCARE CORP. |
| K991667 | BROADLINE OR TOWELS | Sep 27, 1999 | Substantially Equivalent | BROADLINE MEDICAL INDUSTRIES |
| K990253 | SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600 | Sep 24, 1999 | Substantially Equivalent | AMBA MEDICAL LTD. |
| K991548 | HAL SCOPE HOLDER SYSTEM | Jun 23, 1999 | Substantially Equivalent | NOVED MEDICAL |
| K981823 | OPERATING ROOM TOWELS | Aug 11, 1998 | Substantially Equivalent | BALDUR SYSTEMS CORP. |
| K981818 | CONVERTORS TRILAMINATE DRAPES | Jul 10, 1998 | Substantially Equivalent | ALLEGIANCE HEALTHCARE CORP. |
| K980210 | VARIOUS SURGICAL OR PATIENT DRAPES | May 15, 1998 | Substantially Equivalent | GEL-LITE, L.L.C. |
| K974672 | MSI SURGICAL DRAPES | Mar 13, 1998 | Substantially Equivalent | MEDICAL SPECIALTY INNOVATIONS, INC. (MSI) |
| K980183 | PROMAX SURGICAL DRAPES AND COVERS | Feb 26, 1998 | Substantially Equivalent | STANDARD TEXTILE CO., INC. |
| K974647 | FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633 | Jan 05, 1998 | Substantially Equivalent | CUSTOMED, INC. |
| K973146 | MENTOR SUPER ABSORBENT DRAPE | Dec 04, 1997 | Substantially Equivalent | MENTOR OPHTHALMICS, INC. |
| K970889 | ULTRASOUND TRANSDUCER DRAPE | Oct 20, 1997 | Substantially Equivalent | PROTEK MEDICAL PRODUCTS, INC. |
| K971089 | OPPORTUNITY, INC. LACERATION TRAY | Sep 16, 1997 | Substantially Equivalent for Some Indications | OPPORTUNITY, INC. |
| K972187 | BOUFFANT CAP | Sep 09, 1997 | Substantially Equivalent | AMERICAN SEAL CO. |
| K970891 | DRAPE, SURGICAL-LATEX | Aug 22, 1997 | Substantially Equivalent | PROTEK MEDICAL PRODUCTS, INC. |
| K971159 | SURGICAL DRAPES | Jun 24, 1997 | Substantially Equivalent | INTERNATIONAL MEDSURG CONNECTION |
| K970554 | CONVERTORS SMS DRAPES | May 27, 1997 | Substantially Equivalent | ALLEGIANCE HEALTHCARE CORP. |
| K970185 | STERILE DISPOSABLE EQUIPMENT MAGNET COVER | Apr 10, 1997 | Substantially Equivalent | CONTOUR FABRICATORS, INC. |
| K970722 | EYE TRAY | Mar 31, 1997 | Substantially Equivalent | TRINITY LABORATORIES, INC. |
| K964142 | MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS | Feb 25, 1997 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K963675 | THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE | Jan 27, 1997 | Substantially Equivalent | MICRO-MEDICAL DEVICES, INC. |
| K964125 | CONVERTORS DRAPE MATERIAL | Dec 23, 1996 | Substantially Equivalent | ALLEGIANCE HEALTHCARE CORP. |
| K962205 | STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE | Nov 26, 1996 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K955749 | TEX-CARE STERILE STOCKINETTE | Nov 22, 1996 | Substantially Equivalent | FLYNT AMTEX, INC. |
| K962003 | TUAT SPLATTER CONTROL SHIELD SCS-300 | Jul 18, 1996 | Substantially Equivalent | TAUT, INC. |
| K960803 | RX TEXTILES STERILE STOCKINETTE | Jul 12, 1996 | Substantially Equivalent | RX TEXTILES, INC. |
| K960045 | ENVIROTEX REUSABLE O.R. WRAPPER AND CUSTOM SURGICAL DRAPE | Jun 05, 1996 | Substantially Equivalent | THE SEWING SOURCE, INC. |
| K954824 | PROTECTOR RETRACTOR & PROTECTOR RETRACTOR WITH DRAPE | Apr 23, 1996 | Substantially Equivalent | MEDICAL CREATIVE TECHNOLOGIES, INC. |
| K960242 | CPR EYE TRAY | Mar 12, 1996 | Substantially Equivalent | CUSTOM PACK RELIABILITY |
| K955872 | VOLMED OPERATION DRAPE | Mar 12, 1996 | Substantially Equivalent | MEDAL INTL. SALES CO., LLC. |
| K950565 | DEROYAL SURGICAL INSTRUMENT DRAPE | Dec 13, 1995 | Substantially Equivalent | DEROYAL INDUSTRIES, INC. |
| K954212 | CONTAMINATION CONTAINMENT DRAPE | Oct 23, 1995 | Substantially Equivalent | ENGINEERING CONTROLS FOR MEDICINE |
| K952759 | TOWEL PACK | Sep 29, 1995 | Substantially Equivalent | MEDCARE CUSTOM PACKAGING, INC. |
| K953654 | ORS-111 | Sep 22, 1995 | Substantially Equivalent | O.R. SOLUTIONS, INC. |
| K933148 | SURGICAL DRAPE KIT | Jun 26, 1995 | Substantially Equivalent | NOBELPHARMA USA, INC. |
| K945755 | OREX(R) O.R EQUIPMENT DRAPES | May 25, 1995 | Substantially Equivalent | THANTEX SPECIALTIES, INC. |
| K951214 | STERILE EQUIPMENT COVER | May 16, 1995 | Substantially Equivalent | GULFSTREAM MEDICAL |
| K950830 | STA-PUT NON-MAGNETIC INSTRUMENT DRAPE CATALOG #100-187-00 (16X20), 100-186-00 (16X10), 100-183-00 W/DEXTER WRAP | May 03, 1995 | Substantially Equivalent | AVAIL-SOUTHWEST DIVISION |
| K941802 | OR TOWEL | May 03, 1995 | Substantially Equivalent | HERMITAGE HOSPITAL PRODUCTS, INC. |
| K946060 | REMINGTON MEDICAL DISPOSABLE FLUORO/EQUIPMENT COVER MODEL RMI8 | Apr 27, 1995 | Substantially Equivalent | REMINGTON MEDICAL, INC. |
| K945656 | THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE | Mar 28, 1995 | Substantially Equivalent | MICRO-MEDICAL DEVICES, INC. |
| K945486 | SPLATTER CONTROL SHIELD | Feb 28, 1995 | Substantially Equivalent | TAUT, INC. |
| K944863 | COMPEL SURGICALDRAPES | Feb 28, 1995 | Substantially Equivalent | STANDARD TEXTILE CO., INC. |
| K944859 | OREX SURGICAL DRAPES | Feb 28, 1995 | Substantially Equivalent | THANTEX SPECIALTIES, INC. |
| K946024 | 3M PEDIATRIC LAPAROTOMY SHEET #7938/ #7938NS | Feb 08, 1995 | Substantially Equivalent | 3M HEALTH CARE |
| K946025 | 3M X-LARGE SHEET #7979/ #7979NS | Feb 02, 1995 | Substantially Equivalent | 3M HEALTH CARE |
| K943393 | CIVCO PROBE BOOT/CORD COVER | Feb 02, 1995 | Substantially Equivalent | CIVCO MEDICAL INSTRUMENTS CO., INC. |
| K942294 | ASEP PLUS SURGICAL DRAPES | Jan 02, 1995 | Substantially Equivalent | ANGELICA UNIFORM |
| K942228 | OREX O.R. TOWEL | Dec 20, 1994 | Substantially Equivalent | THANTEX SPECIALTIES, INC. |
| K931267 | CONVERTORS ISO BAC DRAPE MATERIAL | Nov 07, 1994 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K934630 | UNIVERSAL VIDEO/LASER ARM DRAPE | Oct 28, 1994 | Substantially Equivalent | HYDRO-MED PRODUCTS, INC. |
| K923960 | UPPER EXTERMITY DRAPE KIT | Oct 07, 1994 | Substantially Equivalent | MEDIKMARK, INC. |
| K931143 | AMSCO STERILE RECOVERIES ABSORBENT TOWELS | Sep 08, 1994 | Substantially Equivalent | AMSCO STERILE RECOVERIES, INC. |
| K943122 | SURGICAL DRAPES | Sep 07, 1994 | Substantially Equivalent | MALLINCKRODT GROUP, INC. |
| K941233 | GLOBAL SHOULDER O.R. DRAPE PACK | Jul 27, 1994 | Substantially Equivalent | DEPUY, INC. |
| K931146 | SURGICAL DRAPES, MODIFICATION | Jun 13, 1994 | Substantially Equivalent | AMSCO STERILE RECOVERIES, INC. |
| K940175 | MEDSURG STERILE O.R. TOWELS | May 26, 1994 | Substantially Equivalent | MEDSURG INDUSTRIES, INC. |
| K941302 | STERILE IMPERVIOUS ORTHOPEDIC STOCKINETTE | May 12, 1994 | Substantially Equivalent | CUSH INDUSTRIES, INC. |
| K931455 | HEAD SHEET | May 05, 1994 | Substantially Equivalent | CUSTOM MEDICAL PRODUCTS, LTD. |
| K931418 | SURGICAL DRAPE | May 05, 1994 | Substantially Equivalent | CUSTOM MEDICAL PRODUCTS, LTD. |
| K930815 | ABDOMINAL / THORACIC PATIENT DRAPE | May 05, 1994 | Substantially Equivalent | CUSTOM MEDICAL PRODUCTS, LTD. |
| K940702 | CONVERTORS OPTI-SORB DRAPE MATERIAL | Apr 26, 1994 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K934445 | STSTORZ DP5300 AND DP9502 STERILE DRAPES | Apr 11, 1994 | Substantially Equivalent | STORZ INSTRUMENT CO. |
| K924101 | STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE | Apr 11, 1994 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K934215 | CONTAIN-OR | Feb 09, 1994 | Substantially Equivalent | DLP, INC. |
| K936210 | NPAC | Feb 03, 1994 | Substantially Equivalent | NATIONAL HEALTHCARE LINEN SERVICE |
| K932253 | ARTHROBOT BI-FOLD DRAPE | Feb 03, 1994 | Substantially Equivalent | ANDRONIC DEVICES, LTD. |
| K931091 | DISPOSABLE AMA STERILE DRAPE SHEET, CAT. NO. 5252 | Feb 03, 1994 | Substantially Equivalent | ALLIANCE MEDICAL, INC. |
| K933382 | IMC CABLE/WIRE COVER | Jan 27, 1994 | Substantially Equivalent | INMAN MEDICAL CORP. |
| K932857 | ABDOMINAL FLUID CONTROL POUCH, 203-301-S;ETC. | Sep 13, 1993 | Substantially Equivalent | ANSLEY MEDICAL PRODUCTS, INC. |
| K924335 | DRAPES | Sep 07, 1993 | Substantially Equivalent | PFB INTER-APPAREL CORP. |
| K922918 | BARRIER SAF-TE HYDROGEL DRAPE | Jul 06, 1993 | Substantially Equivalent | JOHNSON & JOHNSON INTERNATIONAL |
| K922962 | VARIOUS CAMEO MED BASIC BIOPSY TRAYS, DISPOSABLE | Mar 23, 1993 | Unknown | CAMEO, INC. |
| K922961 | VARIOUS CAMEO MED PERCUTANEOUS SKIN PREP TRAYS, | Mar 23, 1993 | Unknown | CAMEO, INC. |
| K921657 | VASECTOMY DRAPE | Mar 18, 1993 | Substantially Equivalent | GRAHAM MEDICAL PRODUCTS |
| K922059 | DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599 | Mar 03, 1993 | Substantially Equivalent | GRAHAM MEDICAL PRODUCTS |
| K920346 | VARIOUS UTILITY/SURGICAL DRAPE, STERILE, DISPOSABL | Mar 03, 1993 | Substantially Equivalent | TRINITY LABORATORIES, INC. |
| K923811 | COMPEL SURGICAL DRAPES | Feb 23, 1993 | Substantially Equivalent | STANDARD TEXTILE CO., INC. |
| K920808 | OB/GYN DRAPE | Feb 19, 1993 | Substantially Equivalent | PREFERRED MEDICAL PRODUCTS |
| K923798 | SURGICAL GOWN PACK | Jan 27, 1993 | Substantially Equivalent | CENTRAL GEORGIA ANCILLARY HEALTH SYSTEMS |
| K923688 | N-PAC | Jan 27, 1993 | Substantially Equivalent | NATIONAL HEALTHCARE LINEN SERVICE |
| K923283 | SUP 5415 SINGLE USE ONLY STERILE HOSPITAL KIT | Jan 04, 1993 | Unknown | SAVOY MEDICAL SUPPLY CO., INC. |
| K920284 | DRAPE UTILITY/SURGICAL STERILE DISPOSABLE | Oct 19, 1992 | Substantially Equivalent | TRINITY LABORATORIES, INC. |
| K921049 | SURGICAL DRAPE | Oct 01, 1992 | Substantially Equivalent | AMSCO STERILE RECOVERIES, INC. |
| K922828 | ULCER WOUND TRAY | Sep 28, 1992 | Unknown | ULTI-MED INTL., INC. |
| K920518 | E.R. SUTURE TRAY, STERILE, DISPOSABLE | Aug 17, 1992 | Unknown | TRINITY LABORATORIES, INC. |
| K921394 | DRESSING CHANGE TRAY, STERILE, DISPOSABLE | Aug 13, 1992 | Unknown | TRINITY LABORATORIES, INC. |
| K921204 | DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLE | Aug 13, 1992 | Unknown | TRINITY LABORATORIES, INC. |
| K921203 | INCISSION & DRAINAGE TRAY | Aug 13, 1992 | Unknown | TRINITY LABORATORIES, INC. |
| K921350 | QUALTEX TUBE/CORD ORGANIZER | Aug 04, 1992 | Substantially Equivalent | DEROYAL INDUSTRIES, INC. |
| K920045 | DURATECH HOSPITAL TOWEL | Jul 02, 1992 | Substantially Equivalent | TECHSTYLES |
| K915740 | DISPOSABLE O.R. TOWEL, STERILE | Jun 22, 1992 | Substantially Equivalent | AMERICAN THRESHOLD INDUSTRIES, INC. |
| K920995 | BARRIER DRAPE SHEET WITH SYMETRY FABRIC | May 31, 1992 | Substantially Equivalent | JOHNSON & JOHNSON MEDICAL, INC. |
| K920517 | MINOR LACERATION TRAY W/ INSTRUMENT, STERILE, DISP | May 11, 1992 | Unknown | TRINITY LABORATORIES, INC. |
| K920341 | LACERATION TRAYS | Apr 23, 1992 | Unknown | MEDIKMARK, INC. |
| K920340 | SUTURE REMOVAL KIT | Apr 23, 1992 | Unknown | MEDIKMARK, INC. |
| K914761 | KAY-MED SURGICAL DEAPE/DRAP ACCESSORIES | Apr 06, 1992 | Substantially Equivalent | KAYCO MEDICAL, INC. |
| K920052 | HEALTH PAK TRAY SOX BARRIERS | Apr 03, 1992 | Substantially Equivalent | HEALTHPAK, INC. |
| K913408 | STERILE PLASTIC DRAPE | Mar 12, 1992 | Substantially Equivalent | ACACIA LABORATORIES, INC. |
| K913448 | DISPOSABLE TURP FLUID CONTAINMENT DRAPE - STERILE | Feb 07, 1992 | Substantially Equivalent | GRAHAM MEDICAL PRODUCTS |
| K913447 | DISPOSABLE CYSTOSCOPY SPLASH DRAPE-STERILE #599 | Feb 07, 1992 | Substantially Equivalent | GRAHAM MEDICAL PRODUCTS |
| K913486 | QUALTEX SURGICAL DRAPE, MODIFICATION | Feb 05, 1992 | Substantially Equivalent | DEROYAL INDUSTRIES, INC. |
| K914929 | LACERATION TRAY | Jan 31, 1992 | Unknown | WESTMARK HOSPITAL SUPPLIES |
| K914605 | MULTIPLE STERILE SURGICAL DRAPE PACK | Jan 15, 1992 | Unknown | ASSURED SURGICAL PRODUCTS, INC. |
| K915214 | ARTHROSCOPY CAMERA DRAPE | Jan 09, 1992 | Substantially Equivalent | O.R. CONCEPTS, INC. |
| K914369 | QUALTEX MAGNETIC INSTRUMENT DRAPE | Dec 02, 1991 | Substantially Equivalent | DEROYAL INDUSTRIES, INC. |
| K913536 | PRC AUTOPSY DEVICE | Nov 22, 1991 | Substantially Equivalent | PENNSTATE |
| K913506 | CONVERTORS SAFECARE GOWN & DRAPE MATERIAL | Oct 11, 1991 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K913382 | MEGA PARACENTESIS KIT | Oct 08, 1991 | Substantially Equivalent | MEGA MEDICAL, INC. |
| K911944 | MEDI GUARD DENTAL BIB | Oct 04, 1991 | Substantially Equivalent | SANCELLA, INC. |
| K913047 | STERILESERT(TM) CABLE AND POLE DRAPE | Oct 02, 1991 | Substantially Equivalent | ARCH DEVELOPMENT GROUP |
| K912947 | STARPAC O.R. TOWEL | Sep 23, 1991 | Substantially Equivalent | MULTI M INTL., INC. |
| K911131 | STERILE SURGICAL GOWN PACK | Sep 16, 1991 | Substantially Equivalent | CENTRAL GEORGIA ANCILLARY HEALTH SYSTEMS |
| K904873 | STERILE SURGICAL PACK | Aug 29, 1991 | Substantially Equivalent | ANGELICA HEALTHCARE SERVICES |
| K912490 | CITATION MEDICAL SCOPE PROCEDURE PACK | Aug 16, 1991 | Substantially Equivalent | CITATION MEDICAL CORP. |
| K911565 | CUSTOM PROCEDURE TRAY | Aug 09, 1991 | Substantially Equivalent | VANGUARD MEDICAL CONCEPTS, INC. |
| K911521 | ARTHROBOT(TM) 96 (240 CM) DRAPE WITH 1 STRAP | Aug 02, 1991 | Substantially Equivalent | ANDRONIC DEVICES, LTD. |
| K911520 | ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE DRAPE | Aug 02, 1991 | Substantially Equivalent | ANDRONIC DEVICES, LTD. |
| K912110 | DISPOSABLE O.R. TOWEL | Jul 25, 1991 | Substantially Equivalent | AMERICAN THRESHOLD INDUSTRIES, INC. |
| K912542 | PURITAS 100% COTTON ABSORB OPER ROOM SURG TOWELS | Jul 23, 1991 | Substantially Equivalent | PURITAS HEALTH CARE, INC. |
| K911510 | MAGNA SURGICAL PACKS | Jun 17, 1991 | Unknown | DMS MIAMI, INC. |
| K911509 | MAGNA OBSTETRICAL PACKS | Jun 17, 1991 | Unknown | DMS MIAMI, INC. |
| K905803 | HALE SUN SURGICAL TOWEL OR O.R. TOWEL | May 21, 1991 | Substantially Equivalent | HALE SUN INDUSTRIES, LTD. |
| K911039 | INVOTEC EAR DRAPE | May 13, 1991 | Substantially Equivalent | INVOTEC INTERNATIONAL, INC. |
| K910084 | SURGICAL DRAPE | Mar 19, 1991 | Substantially Equivalent | BIOCOR MEDICAL, INC. |
| K904957 | STERILE AND NON-STERILE TEXTILE PACKS | Feb 21, 1991 | Substantially Equivalent | SURGICAL PACK SERVICES, INC. |
| K910495 | QUALTEX SURGICAL DRAPE | Feb 19, 1991 | Substantially Equivalent | DEROYAL INDUSTRIES, INC. |
| K905701 | RICHARD-ALLAN SHEET CLIP | Feb 19, 1991 | Substantially Equivalent | RICHARD-ALLAN MEDICAL |
| K905466 | STERILE DISPOSABLE SURGICAL DRAPE/ABDOMINAL DRAPE | Feb 11, 1991 | Substantially Equivalent | ANGIOSYSTEMS, INC. |
| K905465 | STERILE DISPOS SURGICAL DRAPE/C-SECTION DRAPE | Feb 11, 1991 | Substantially Equivalent | ANGIOSYSTEMS, INC. |
| K904694 | CUSTOMED ANGIODRAPE PACK FEMORAL | Jan 02, 1991 | Unknown | CUSTOMED, INC. |
| K904693 | CUSTOMED CARDIOVASCULAR PACK | Jan 02, 1991 | Unknown | CUSTOMED, INC. |
| K903117 | ORION STERILE OR TOWELS | Dec 31, 1990 | Substantially Equivalent | ORION LIFE SYSTEMS, INC. |
| K904960 | QUALTEX SURGICAL DRAPE | Dec 13, 1990 | Substantially Equivalent | DEROYAL INDUSTRIES, INC. |
| K905005 | DISPOSABLE SURGICAL TOWEL (NON-STERILE) | Dec 11, 1990 | Substantially Equivalent | MARAND PRODUCTS, INC. |
| K903346 | DISPOSABLE EMISSIONS BARRIER LASER DRAPE | Dec 05, 1990 | Substantially Equivalent | WAVE-FORM SYSTEMS, INC. |
| K902191 | CUSTOMED LAP PACK II | Oct 31, 1990 | Substantially Equivalent | CUSTOMED, INC. |
| K901705 | CUSTOMED CYSTO PACK II | Oct 31, 1990 | Substantially Equivalent | CUSTOMED, INC. |
| K904112 | STI DRAPE SHEET STYLE 1908 | Oct 30, 1990 | Substantially Equivalent | STERILIZER TECHNOLOGIES CORP. |
| K903908 | REPAK SURGICAL PACKS | Oct 26, 1990 | Substantially Equivalent | REPACK SURGICAL ENTERPRISES, INC. |
| K902715 | SURGICAL TOWEL | Sep 28, 1990 | Substantially Equivalent | AZTEC MEDICAL, INC. |
| K902886 | CUSTOMED BASIC PACK III | Sep 19, 1990 | Substantially Equivalent | CUSTOMED, INC. |
| K902885 | CUSTOMED BASIC PACK II | Sep 19, 1990 | Substantially Equivalent | CUSTOMED, INC. |
| K902884 | CUSTOMED BASIC PACK I | Sep 19, 1990 | Substantially Equivalent | CUSTOMED, INC. |
| K903726 | DRAPE, SURGICAL - UTILITY DRAPE - STERILE | Aug 27, 1990 | Substantially Equivalent | GRAHAM MEDICAL PRODUCTS |
| K902384 | ABDOMINAL OR C-SECTION DRAPE SHEET | Aug 09, 1990 | Substantially Equivalent | MEDICAL PLASTICS, INC. |
| K902031 | CUSTOMED LAP PACK IV | Jul 12, 1990 | Substantially Equivalent | CUSTOMED, INC. |
| K902030 | CUSTOMED LAP PACK III | Jul 12, 1990 | Substantially Equivalent | CUSTOMED, INC. |
| K902029 | CUSTOMED LAP PACK I | Jul 12, 1990 | Substantially Equivalent | CUSTOMED, INC. |
| K901465 | ABSORBABLE GAUZE DRAPE | Jun 12, 1990 | Substantially Equivalent | ULTI-MED INTL., INC. |
| K900945 | LAMIN-ADD ADHESIVE SURGICAL DRAPE & CATH. DRESSING | May 09, 1990 | Substantially Equivalent | PALEX MEDICAL, INC. |
| K896215 | MERCY HIP/KNEE PACK | Feb 13, 1990 | Substantially Equivalent | WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) |
| K897120 | EQUIP COVERS, STERILE | Jan 04, 1990 | Substantially Equivalent | AMEDIC USA |
| K896367 | STERILE SURGICAL DRAPES AND SHEETS | Dec 04, 1989 | Substantially Equivalent | CLINITECH, INC. |
| K895404 | UNDER BUTTOCKS DRAPE | Oct 06, 1989 | Substantially Equivalent | MEDICAL PLASTICS, INC. |
| K895011 | TRIDENT DRAPE SUPPORT | Sep 15, 1989 | Substantially Equivalent | TRIDENT MEDICAL PRODUCTS, INC. |
| K894764 | OR TOWEL PACKS | Aug 18, 1989 | Substantially Equivalent | ADVANCE MEDICAL DESIGNS, INC. |
| K894436 | MASCOT O.R. TOWEL | Aug 11, 1989 | Substantially Equivalent | MASCOT, INC. |
| K894433 | BATES BLANKET | Aug 11, 1989 | Substantially Equivalent | JOE B. BATES, MD, FAAP |
| K893212 | THERMALAP | Jun 01, 1989 | Substantially Equivalent | O.R. CONCEPTS, INC. |
| K884231 | SURGICAL 'LASER' DRAPE | Apr 20, 1989 | Substantially Equivalent | HENLEY INTL. |
| K885099 | MULTIPLE (STERILE SURGICAL TOWELS) | Mar 22, 1989 | Substantially Equivalent | MED-TEX, INC. |
| K890101 | FEMORAL ANGIOGRAPHY DRAPE | Mar 16, 1989 | Substantially Equivalent | MEDICAL PLASTICS, INC. |
| K890709 | O.R. TOWELS (STERILE) | Mar 14, 1989 | Substantially Equivalent | CYPRESS MEDICAL PRODUCTS, LTD. |
| K882643 | AM TM SYRGICAL DRAPES | Mar 03, 1989 | Substantially Equivalent for Some Indications | HENLEY INTL. |
| K890471 | PMS ANGIO DRAPE | Feb 27, 1989 | Substantially Equivalent | PROFESSIONAL MEDICAL SERVICES |
| K890006 | BAXTER STERILE TOWEL | Jan 24, 1989 | Substantially Equivalent | HEALTHMED CORP. |
| K884057 | ELAN-E DISPOSABLE DRAPE | Oct 19, 1988 | Substantially Equivalent | AESCULAP INSTRUMENTS CORP. |
| K884112 | CARETEX OR TOWEL | Oct 13, 1988 | Substantially Equivalent | JAMES RIVER CORP. |
| K883424 | SURGICAL GOWN/SCRUB/LAPAROTOMY/MAYO STAND/BACK TAB | Sep 06, 1988 | Substantially Equivalent | INTERA CORP. |
| K882000 | PRO-FECT O.R. TOWEL | Aug 26, 1988 | Substantially Equivalent | NETWORK TRADING CORP. |
| K882724 | MICROTEK PROBE DRAPE | Aug 03, 1988 | Substantially Equivalent | MICROBIO-MEDICS, INC. |
| K882494 | ELAN-E DISPOSALBE DRAPE | Jul 08, 1988 | Substantially Equivalent | DERMACARE PRODUCTS, INC. |
| K881396 | OPERATING ROOM TOWELS -STERILE & NON-STERILE | Apr 29, 1988 | Substantially Equivalent | A PLUS INTERNATIONAL, INC |
| K881479 | OPERATION ROOM TOWEL | Apr 14, 1988 | Substantially Equivalent | RAHN LABORATORIES |
| K880513 | DISP. NON-MAGNETIC SURGICAL INSTRU. DRAPE | Mar 11, 1988 | Substantially Equivalent | TAUB INDUSTRIES |
| K875153 | THIELER KIT | Feb 18, 1988 | Substantially Equivalent | TARIS CORP. |
| K874086 | 3M BRAND LASER PROTECTION SURGICAL DRAPES, 88XX | Dec 17, 1987 | Substantially Equivalent | 3M COMPANY |
| K873141 | LASER RESISTANT DRAPE | Oct 23, 1987 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K873313 | SURGICAL DRAPE | Sep 04, 1987 | Substantially Equivalent | AMERICAN MEDICAL TECHNOLOGY, INC. |
| K872757 | OPSITE SPECIALITY DRAPES | Jul 28, 1987 | Substantially Equivalent | SMITH & NEPHEW, INC. |
| K872395 | CK 1600 SERIES, TOWELS | Jul 02, 1987 | Substantially Equivalent | CURRIE MEDICAL SPECIALTIES, INC. |
| K871068 | DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER | May 28, 1987 | Substantially Equivalent | LIFESTREAM INT'L, INC. |
| K864388 | MODIFIED DISPOSABLE STERILE TOWEL USED IN SURGERY | Feb 20, 1987 | Substantially Equivalent | DEROYAL INDUSTRIES, INC. |
| K870124 | SURGICAL DRAPES AND ACCESSORIES USING PEBAX FILM | Feb 04, 1987 | Substantially Equivalent | AVERY INTL. |
| K870123 | SURGICAL DRAPES AND ACCESSORIES USING PCCE FILM | Feb 04, 1987 | Substantially Equivalent | AVERY INTL. |
| K870122 | SURGICAL DRAPES AND ACCESSORIES USING HYTREL FILM | Feb 04, 1987 | Substantially Equivalent | AVERY INTL. |
| K865094 | LINEN (HUCK) TOWEL | Jan 20, 1987 | Substantially Equivalent | THE EYE CO-OP, INC. |
| K864899 | SURGICAL DRAPE PACK | Jan 20, 1987 | Substantially Equivalent | WEBSTER ENTERPRISES, INC. |
| K864697 | CK 6000 SERIES, TOWELS | Dec 18, 1986 | Substantially Equivalent | CURRIE MEDICAL SPECIALTIES, INC. |
| K864111 | STERILE FIELD #605 FENESTRATED STERILE FIELD #606 | Oct 30, 1986 | Substantially Equivalent | GRAHAM MEDICAL PRODUCTS |
| K863323 | SENGEWALD CATALOG NUMBER 55 66 01 | Oct 29, 1986 | Substantially Equivalent | SENGEWALD/USA, INC. |
| K863871 | OPERATING ROOM TOWELS - STERILE/NON STERILE | Oct 24, 1986 | Substantially Equivalent | MED-TEX, INC. |
| K863732 | SURGICAL DRAPE & DRAPE ACCESSORIES | Oct 23, 1986 | Substantially Equivalent | INTERA CORP. |
| K863512 | DRAPE STERICOVER | Sep 30, 1986 | Substantially Equivalent | STERIMED, INC. |
| K862801 | SPUNGUARD PLUS SURGICAL DRAPE | Aug 07, 1986 | Substantially Equivalent | KIMBERLY-CLARK CORP. |
| K862577 | LINEN (HUCK) TOWEL | Jul 23, 1986 | Substantially Equivalent | DIMED, INTL. |
| K862438 | SURGICAL DRAPES AND DRAPE ACCESSORIES | Jul 16, 1986 | Substantially Equivalent for Some Indications | AVERY INTL. |
| K862172 | QUALI-MED'S OPERATING ROOM DRAPES | Jun 19, 1986 | Substantially Equivalent | QUALI-MED, INC. |
| K862062 | NONWOVEN SURGICAL DRAPE PACK | Jun 10, 1986 | Substantially Equivalent | EAST TEXAS LIGHTHOUSE FOR THE BLIND |
| K862016 | PACH-PEN SURGICAL DRAPE | Jun 04, 1986 | Substantially Equivalent | OCULAB, INC. |
| K861969 | STERILE TOWEL W/ANTIMICROBIAL AGENT | Jun 04, 1986 | Substantially Equivalent | DEROYAL INDUSTRIES, INC. |
| K861531 | DISPOSABLE SURGICAL DRAPES AND ACCESSORIES | May 23, 1986 | Substantially Equivalent | MEDICAL CONCEPTS DEVELOPMENT, INC. |
| K861288 | NON-STERILE & STERILE DISPOSABLE SURGICAL DRAPES | May 06, 1986 | Substantially Equivalent | PROCEDURE PAK, INC. |
| K861196 | STERILE STOCKINETTE W/ANTIMICROBIAL AGENT | Apr 30, 1986 | Substantially Equivalent | DEROYAL INDUSTRIES, INC. |
| K860936 | ABSORBENT, FIBER, OPERATING ROOM TOWELS | Apr 04, 1986 | Substantially Equivalent | ULTI-MED INTL., INC. |
| K850960 | NON-ABSORBENT DRAPES & ABSORBENT TOWELS | Mar 15, 1986 | Substantially Equivalent | EXCEL HEALTH CARE PRODUCTS |
| K860326 | TUBULAR ORTHO. STOCKINETTE W/ANTIMICROBIAL AGENT | Feb 21, 1986 | Substantially Equivalent | DEROYAL INDUSTRIES, INC. |
| K860447 | STANGUARD O.R. TOWEL PACK-4TOWEL PACK #278220400 | Feb 19, 1986 | Substantially Equivalent | STANDARD TEXTILE CO., INC. |
| K860248 | 100% COTTON ABSORBENT TOWEL | Feb 19, 1986 | Substantially Equivalent | DEVON INDUSTRIES, INC. |
| K853347 | MAI STERILE UTILITY DRAPE | Sep 05, 1985 | Substantially Equivalent | MEDICAL ASSOC. INTL., INC. |
| K852945 | HUCK TOWEL | Jul 29, 1985 | Substantially Equivalent | SOUTH MOUNTAIN MEDICAL |
| K852280 | DRAPES(SURGICAL, GENERAL & PLASTIC SURGERY) | Jul 09, 1985 | Substantially Equivalent | OUTPATIENT PRODUCTS CO. |
| K850912 | STERILE DISPOSABLE PN DRAPE SYSTEM | May 03, 1985 | Substantially Equivalent | BRANT-WALD SURGICALS, INC. |
| K851314 | ABCO DRAPES/TOWELS | May 01, 1985 | Substantially Equivalent | ABCO DEALERS, INC. |
| K850326 | STERILE FILM DRAPE FENESTRATED W/ADHESIVE PATCH | Feb 26, 1985 | Substantially Equivalent | EXCEL HEALTH CARE PRODUCTS |
| K850199 | POLY-LINED TOWEL/DRAPE LINE | Feb 21, 1985 | Substantially Equivalent | EXCEL HEALTH CARE PRODUCTS |
| K844802 | SURGICAL DRAPES | Jan 14, 1985 | Substantially Equivalent | PROCTER & GAMBLE MFG. CO. |
| K843724 | I.V. START KIT & OBSTETRICAL KIT | Jan 10, 1985 | Substantially Equivalent | E.M. ADAMS |
| K844465 | PMS DRAPE PACK | Dec 05, 1984 | Substantially Equivalent | PROFESSIONAL MEDICAL SERVICES |
| K844199 | ELASTIC STYLE IMPERVIOUS ORTHOPEDIC STOCKINET | Nov 07, 1984 | Substantially Equivalent | KLEEN TEST PRODUCTS |
| K843496 | DRAPE SURGICAL UTILITY DRAPE STERILE | Oct 31, 1984 | Substantially Equivalent | BUSSE HOSPITAL DISPOSABLES, INC. |
| K843260 | ANGIOSYS FEMORAL ANGIOGRAPHY DRAPE | Sep 21, 1984 | Substantially Equivalent | ANGIOSYSTEMS, INC. |
| K841735 | ACU-DERM TRANSPARENT INCISE DRAPE | Aug 02, 1984 | Substantially Equivalent | ACME UNITED CORP. |
| K842545 | ALL-HANDS STERILE FIELD-0201 | Aug 01, 1984 | Substantially Equivalent | ALL-HANDS MEDICAL SUPPLY, INC. |
| K842115 | SPUNGARD & SURG. DRAPES-GOWNS & PACKS | Jun 11, 1984 | Substantially Equivalent | KIMBERLY-CLARK CORP. |
| K840957 | ANTIMICROBIAL INCISE DRAPE | Jun 07, 1984 | Substantially Equivalent | AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL |
| K833176 | SDI SURGICAL DRAPE | Apr 04, 1984 | Substantially Equivalent | SDI |
| K833877 | SINGLE-USE SURGICAL DRAPES | Jan 25, 1984 | Substantially Equivalent | PROCTER & GAMBLE MFG. CO. |
| K833122 | BURLINGTON ANTIMICROBIAL STOCKINEETTE | Jan 25, 1984 | Substantially Equivalent | BALFOUR, INC. |
| K833121 | BURLINGTON STERILE ANTIMICROBIAL STOCK | Jan 25, 1984 | Substantially Equivalent | BALFOUR, INC. |
| K831287 | E-Z FIT | Oct 14, 1983 | Substantially Equivalent | TRIAD MEDICAL DIVISION |
| K832278 | LIGHT HANDLE COVER | Sep 29, 1983 | Substantially Equivalent | CONCEPT, INC. |
| K832874 | ISOVIS WOUND PROTECTOR | Sep 26, 1983 | Substantially Equivalent | RITMED, INC. |
| K830270 | ISOVIS WOUND PROTECTOR | Jun 24, 1983 | Substantially Equivalent | RITMED, INC. |
| K830723 | REDI-DRAPE | Apr 12, 1983 | Substantially Equivalent | THE OEC GROUP |
| K830660 | STERILE SURGICAL DRAPES | Mar 17, 1983 | Substantially Equivalent | PHOENIX GLOVE CO. |
| K823054 | DRAPE, SURGICAL ANGIOGRAPHY | Jan 12, 1983 | Substantially Equivalent | TRIAD MEDICAL DIVISION |
| K822641 | GORE-TEX BARRIER SURG. DRAPES & GOWNS | Jan 07, 1983 | Substantially Equivalent | W.L. GORE & ASSOCIATES,INC |
| K822847 | INSTA-HOLD | Oct 08, 1982 | Substantially Equivalent | TAUB INDUSTRIES |
| K820543 | BARRIER ANTIMICROBIAL INCISE DRAPE | Jul 22, 1982 | Substantially Equivalent | SURGIKOS, INC. |
| K820542 | SURGIKOS INCISE DRAPE | Jun 02, 1982 | Substantially Equivalent | SURGIKOS, INC. |
| K820850 | CURITY PREMIUM CYSTOSCOPY TRAY | May 12, 1982 | Substantially Equivalent | THE KENDAL CO. |
| K820758 | BOUNDARY SINGLE-USE CRANIOTOMY SHEET | Apr 29, 1982 | Substantially Equivalent | THE BUCKEYE CELLULOSE CORP. |
| K813360 | DERMAFILE (CAT. # 38 | Mar 18, 1982 | Substantially Equivalent | EXCO, INC. |
| K813097 | ANAGO STERILE PRODUCTS; STOCKINETTES | Mar 10, 1982 | Substantially Equivalent | ANAGO, INC. |
| K820078 | DRAPE, SURGICAL | Feb 04, 1982 | Substantially Equivalent | JAMES L. GERACI & ASSOCIATES, INC. |
| K813450 | BOUNDARY SINGLE-USE DRAPES | Jan 22, 1982 | Substantially Equivalent | THE BUCKEYE CELLULOSE CORP. |
| K813551 | SHEETS | Jan 18, 1982 | Substantially Equivalent | LANCASTER COUNTY ASSOC. FOR THE BLIND |
| K813277 | BOUNDARY DRAPE TAPE | Dec 18, 1981 | Substantially Equivalent | THE BUCKEYE CELLULOSE CORP. |
| K812962 | BOUNDARY SURGICAL DRAPE | Nov 20, 1981 | Substantially Equivalent | THE BUCKEYE CELLULOSE CORP. |
| K812738 | BOUNDARY PROCESS CHANGE | Nov 16, 1981 | Substantially Equivalent | THE BUCKEYE CELLULOSE CORP. |
| K812809 | STERILE ADHERENT DRAPES | Nov 06, 1981 | Substantially Equivalent | ABCO DEALERS, INC. |
| K812448 | UNI-THANE | Oct 02, 1981 | Substantially Equivalent | UNICARE SYSTEMS, INC. |
| K801550 | 3M GERMICIDAL SURGICAL INCISE DRAPE | Sep 17, 1981 | Substantially Equivalent | 3M COMPANY |
| K811871 | BACTERICIDAL INCISE DRAPE | Aug 20, 1981 | Substantially Equivalent | SURGIKOS, INC. |
| K811996 | GATOR DRAPES | Aug 13, 1981 | Substantially Equivalent | THE ANSPACH EFFORT, INC. |
| K802790 | SOLVALINE | Feb 13, 1981 | Substantially Equivalent | SECOL CO. |
| K802980 | DISPOSABLE STERILE LAP SPONGE | Dec 19, 1980 | Substantially Equivalent | ANAGO, INC. |
| K802797 | O.R. DRAPES | Dec 17, 1980 | Substantially Equivalent | SECOL CO. |
| K802787 | METALLINE DRESSINGS | Dec 17, 1980 | Substantially Equivalent | SECOL CO. |
| K802652 | BOUNDARY SURGICAL DRAPES WITH ADHESIVE | Nov 12, 1980 | Substantially Equivalent | PROCTER & GAMBLE MFG. CO. |
| K802537 | DISPOSABLE SURGICAL DRAPE | Nov 12, 1980 | Substantially Equivalent | TEXAS MEDICAL PRODUCTS, INC. |
| K802359 | DISP. FENESTRATED SURG. DRAPE SHEETS | Oct 31, 1980 | Substantially Equivalent | AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL |
| K802317 | COMFORT CUSHION DRY BURN PADS, STERILE | Oct 31, 1980 | Substantially Equivalent | AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL |
| K802280 | WHITE KNIGHT DRAPE SEAL | Oct 10, 1980 | Substantially Equivalent | G.D. SEARLE AND CO. |
| K802213 | WHITE KNIGHT BOVIE CORD/SUCTION TUBE | Oct 10, 1980 | Substantially Equivalent | G.D. SEARLE AND CO. |
| K802247 | BOUNDARY SINGLE-USE DRAPES | Sep 26, 1980 | Substantially Equivalent | PROCTER & GAMBLE MFG. CO. |
| K802192 | BOUNDARY SINGLE-USE DRAPES | Sep 26, 1980 | Substantially Equivalent | PROCTER & GAMBLE MFG. CO. |
| K802148 | BOUNDARY SINGLE-USE DRAPE | Sep 26, 1980 | Substantially Equivalent | PROCTER & GAMBLE MFG. CO. |
| K802050 | TACKMER INCISE DRAPE | Sep 16, 1980 | Substantially Equivalent | AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL |
| K802001 | LAP SPONGES CAT.#801-850 | Sep 16, 1980 | Substantially Equivalent | POLLAK (INTL.), LTD. |
| K801864 | BARRIER APERTURED DRAPE | Aug 20, 1980 | Substantially Equivalent | SURGIKOS, INC. |
| K801863 | BARRIER TOWEL DRAPE | Aug 20, 1980 | Substantially Equivalent | SURGIKOS, INC. |
| K801132 | BOUNDARY EXTREMITY DRAPE | May 20, 1980 | Substantially Equivalent | PROCTER & GAMBLE MFG. CO. |
| K801068 | STERILE ABDOMINAL PAD | May 20, 1980 | Substantially Equivalent | MEDSPEC CORP. |
| K801033 | STERILE DRAPE 17X18 W/3 FENESTRATION | May 20, 1980 | Substantially Equivalent | VERATEX CORP. |
| K801032 | STERILE DRAPE 17X18 CODE D-6A | May 20, 1980 | Substantially Equivalent | VERATEX CORP. |
| K800928 | WHITE KNIGHT SUPPLEMENTAL DRAPE | May 20, 1980 | Substantially Equivalent | G.D. SEARLE AND CO. |
| K800817 | SHIELD DISP. REINFORCED DRAPE SHEETS | May 02, 1980 | Substantially Equivalent | AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL |
| K800278 | MEDSPEC SAFETY PINS | May 02, 1980 | Substantially Equivalent | MEDSPEC CORP. |
| K800552 | ZEISS DISPOSABLE, STERILE SURGICAL DRAPE | Mar 20, 1980 | Substantially Equivalent | CARL ZEISS, INC. |
| K800490 | STERILE DRESSING PACK | Mar 12, 1980 | Substantially Equivalent | MEDI-SPEC |
| K792623 | STERILIZATION PROCESS/ABSORBENT TOWEL | Jan 11, 1980 | Substantially Equivalent | PROCTER & GAMBLE MFG. CO. |
| K792621 | STERILIZATION PROCESS CHANGE BOUNDARY | Jan 11, 1980 | Substantially Equivalent | PROCTER & GAMBLE MFG. CO. |
| K792357 | STERILE IMPERVIOUS ORTHOPEDIC STOCKIN | Dec 18, 1979 | Substantially Equivalent | ALBA-WALDENSIAN, INC. |
| K792176 | DRAPE, MICROSCOPE | Dec 10, 1979 | Substantially Equivalent | CHRIS CO., INC. |
| K791864 | INSTRUMENT PAD | Oct 17, 1979 | Substantially Equivalent | PROCTER & GAMBLE MFG. CO. |
| K791719 | BARRIER & FACE MASK WITH INNER FACING | Oct 04, 1979 | Substantially Equivalent | SURGIKOS, INC. |
| K791500 | BARRIER *450* TAPE STRIP | Aug 28, 1979 | Substantially Equivalent | SURGIKOS, INC. |
| K791486 | FABRIC 450* TOWEL DRAPE | Aug 28, 1979 | Substantially Equivalent | SURGIKOS, INC. |
| K791440 | BARRIER* X-RAY CASSETTE DRAPE | Aug 28, 1979 | Substantially Equivalent | SURGIKOS, INC. |
| K791439 | BARRIER* OVERHEAD TABLE DRAPE | Aug 28, 1979 | Substantially Equivalent | SURGIKOS, INC. |
| K791438 | BARRIER* C-ARM DRAPE | Aug 28, 1979 | Substantially Equivalent | SURGIKOS, INC. |
| K780627 | SURG-O-PAK, GOWNS, SHEETS, AND TOWELS | Jul 11, 1979 | Substantially Equivalent | CONVERTORS |
| K790970 | SURGICAL FACE MASK | Jul 03, 1979 | Substantially Equivalent | CARAPACE, INC. |
| K791070 | ACCU-SORB STERILE STOCKINETTES | Jun 20, 1979 | Substantially Equivalent | MEDLINE INDUSTRIES, INC. |
| K791032 | CARDIAC CATHETERIZATION SHEETS/PACKS | Jun 15, 1979 | Substantially Equivalent | SURGIKOS, INC. |
| K790972 | KIMLON IMPERVIOUS STOCKINETTES | Jun 05, 1979 | Substantially Equivalent | KIMBERLY-CLARK CORP. |
| K790725 | BARRIER SURGICAL DRAPES W/ DRISITE* W/MICROCIDE* | May 11, 1979 | Substantially Equivalent | SURGIKOS, INC. |
| K790636 | KIMLON UNIVERSAL DRAPE | May 08, 1979 | Substantially Equivalent | KIMBERLY-CLARK CORP. |
| K790431 | TREATED BARRIER INCISE DRAPE | May 04, 1979 | Substantially Equivalent | SURGIKOS, INC. |
| K790634 | IMPERVIOUS STERILE STOCKINETTE | Apr 10, 1979 | Substantially Equivalent | ANAGO, INC. |
| K790341 | DELTA-NET | Apr 04, 1979 | Substantially Equivalent | JOHNSON & JOHNSON PROFESSIONALS, INC. |
| K782051 | DRAPES, DISPOSABLE SURGICAL | Mar 21, 1979 | Substantially Equivalent | MARCO MFG. |
| K790234 | DRAPE PACKS, SURGICAL GOWNS | Feb 22, 1979 | Substantially Equivalent | CONVERTORS |
| K790225 | LIMB SHEET WITH FABRIC 450 | Feb 21, 1979 | Substantially Equivalent | SURGIKOS, INC. |
| K790224 | PADIATRY PACK & SHEET WITH FABRIC 450 | Feb 16, 1979 | Substantially Equivalent | SURGIKOS, INC. |
| K790053 | KELLEY-PLUS WITH MEASURETTE | Jan 26, 1979 | Substantially Equivalent | JOHN N. HASWELL, M.D. |
| K782091 | STOCKINETTE, DISPOSABLESURGICAL | Jan 10, 1979 | Substantially Equivalent | ANAGO, INC. |
| K781959 | SURGICAL GOWNS, SHEETS | Jan 10, 1979 | Substantially Equivalent | CONVERTORS |
| K781944 | STOCKINETTE | Dec 29, 1978 | Substantially Equivalent | KIMBERLY-CLARK CORP. |
| K781534 | SURG-O-PAK PREP PAD | Oct 24, 1978 | Substantially Equivalent | CONVERTORS |
| K781172 | U-DRAPE, BOUNDARY | Aug 31, 1978 | Substantially Equivalent | PROCTER & GAMBLE MFG. CO. |
| K780865 | MAGNETIC DRAPE - INSTRUMENT HOLDER | Aug 21, 1978 | Substantially Equivalent | DEVON INDUSTRIES, INC. |
| K780548 | DISPOSA-LOOPS | Aug 21, 1978 | Substantially Equivalent | MEDI-SPEC |
| K781047 | DRAPE, SURGICAL-SPARTAN LIMB SHEET | Aug 18, 1978 | Substantially Equivalent | SPARTAN HEALTHCARE PRODUCTS CO. |
| K781046 | IMPERVIOUS STOCKINET | Aug 18, 1978 | Substantially Equivalent | SPARTAN HEALTHCARE PRODUCTS CO. |
| K780856 | BARRIER GYNECOLOGY PACK FABRIC 450 | Aug 14, 1978 | Substantially Equivalent | SURGIKOS, INC. |
| K780853 | OP-SITE ADHESIVE DRAPES | Aug 14, 1978 | Substantially Equivalent | ACME UNITED CORP. |
| K780844 | BARRIER OBSTETRICAL PACK FABRIC 450 | Aug 14, 1978 | Substantially Equivalent | SURGIKOS, INC. |
| K780843 | BARRIER ABDOMINAL PACK FABRIC 450 | Aug 14, 1978 | Substantially Equivalent | SURGIKOS, INC. |
| K780842 | BARRIER BASIC PACK FABRIC 450 | Aug 14, 1978 | Substantially Equivalent | SURGIKOS, INC. |
| K780841 | BARRIER MEDIUM SHEET 450 | Aug 14, 1978 | Substantially Equivalent | SURGIKOS, INC. |
| K780840 | BARRIER LAPAROTOMY SHEET 450 | Aug 14, 1978 | Substantially Equivalent | SURGIKOS, INC. |
| K780839 | BARRIER PEDIATRIC/INCISE DRAPE 450 | Aug 14, 1978 | Substantially Equivalent | SURGIKOS, INC. |
| K780784 | ASPIRATION NEEDLE | Aug 14, 1978 | Substantially Equivalent | FERRIS MFG. CORP. |
| K780846 | DRAPING MATERIAL, COLBALT 60 STERILE | Jun 19, 1978 | Substantially Equivalent | KIMBERLY-CLARK CORP. |
| K772387 | LEAD HAND | Apr 05, 1978 | Substantially Equivalent | EDWARD WECK, INC. |
| K780036 | TOWEL, DRAPE, BOUNDARY | Jan 24, 1978 | Substantially Equivalent | PROCTER & GAMBLE MFG. CO. |
| K771136 | SURGICAL HEAD DRAPE, DISP. | Jul 14, 1977 | Substantially Equivalent | PROCTER & GAMBLE MFG. CO. |
| K771050 | HYPERALIMENTATION TRAY | Jul 14, 1977 | Substantially Equivalent | AMERICAN HOSPITAL SUPPLY CORP. |
| K771036 | SHAVE PREP TRAY | Jul 14, 1977 | Substantially Equivalent | PARKE-DAVIS CO. |
| K770799 | TRAY, IRRIGATION, STERILE, BASIC | Jun 22, 1977 | Substantially Equivalent | LUKENS CORP. |
| K770796 | SKIN SCRUB PREP SET | Jun 22, 1977 | Substantially Equivalent | LUKENS CORP. |
| K770621 | STOCKINETTE, SURGICAL | Apr 06, 1977 | Substantially Equivalent | THE TORRENT CORP. |
| K770560 | BARRIER O.B. PACK IV | Apr 05, 1977 | Substantially Equivalent | SURGIKOS, INC. |
| K770396 | DRAPES, MODESTY | Mar 23, 1977 | Substantially Equivalent | MARK ONE HEALTHCARE PRODUCTS |
| K760997 | UNDER BOTTOCKS DRAPE | Mar 23, 1977 | Substantially Equivalent | C.R. BARD, INC. |
| K770175 | SEA-BOND ADHEVISE DENTURE CUSHIONS | Feb 04, 1977 | Substantially Equivalent | COMBE, INC. |
| K761204 | BARRIER IMPERVIOUS BACK TABLE COVER | Jan 12, 1977 | Substantially Equivalent | SURGIKOS, INC. |
| K760937 | BARRIER NEURO SHEET | Dec 21, 1976 | Substantially Equivalent | SURGIKOS, INC. |
| K760933 | BARRIER UNIVERSAL SHEET | Nov 11, 1976 | Substantially Equivalent | SURGIKOS, INC. |
| K760932 | BOUNDARY FABRIC III SURGICAL DRAPE | Nov 11, 1976 | Substantially Equivalent | PROCTER & GAMBLE MFG. CO. |
| K760890 | BARRIER IMPERVIOUS S-OCKINETTE | Nov 11, 1976 | Substantially Equivalent | SURGIKOS, INC. |
| K760867 | STERILE STOCKINETTE | Nov 03, 1976 | Substantially Equivalent | ABCO DEALERS, INC. |
| K760807 | BARRIER GENERAL SURGERY PACK | Nov 03, 1976 | Substantially Equivalent | SURGIKOS, INC. |
| K760212 | DRAPES, BARRIER, STERILE PATIENT READY | Aug 11, 1976 | Substantially Equivalent | SURGIKOS, INC. |
FEI Numbers
This FDA classification entry is associated with 219 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 219 registration numbers. Click on an entry to view related FDA registrations.