Product Code: FRG FDA class 2 21 CFR 880.6850

Wrap, Sterilization

General Hospital

A sterilization wrap is a material used to enclose sterilized instruments or supplies, maintaining sterility until the point of use in clinical or surgical settings. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FRG, regulated under 21 CFR 880.6850, within the General Hospital medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

317

FEI Numbers

203

Registration Numbers

203

Unique Applicants

189

Years Active

Basic Information

Product Code: FRG
Device Class: FDA class 2
Regulation Number: 880.6850
Medical Specialty: General Hospital
Review Panel: HO
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 317 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243179	Sterilization Pouch and Roll	Jun 26, 2025	Substantially Equivalent	Yichang Xinxin Paper Products Co., Ltd.
K250321	GCI Sterilization Wrappers	Jun 06, 2025	Substantially Equivalent	George Courey Inc.
K243721	Self Sealing Sterilization Pouches	Apr 25, 2025	Substantially Equivalent	Wellmed Dental Medical Supply Co., Ltd
K250011	Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200); Turbett Surgical Instrument Pod (TS1000)	Apr 04, 2025	Substantially Equivalent	Turbett Surgical
K241565	Sterilization Package/Reel	Feb 24, 2025	Substantially Equivalent	Anqing Clean Dental Instrument Technology Co., Ltd.
K243431	Medicom Sterilization Pouch and Reel	Feb 21, 2025	Substantially Equivalent	Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.
K242898	Sterilization Pouches and Reels	Feb 21, 2025	Substantially Equivalent	Shanghai Jianzhong Medical Packaging Co., Ltd.
K240438	CDB Hospital ® Sterilization Wrap (70 gsm); CDB Hospital ® Sterilization Wrap (44 gsm)	Nov 04, 2024	Substantially Equivalent	Comercializadora Brever
K242839	Safe Secure Sterilization Pouches and Rolls	Oct 16, 2024	Substantially Equivalent	Shenzhen SafeSecure Medical Infection Control Tech Co., Ltd.
K242208	PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)	Oct 07, 2024	Substantially Equivalent	PRIMED Medical Products Inc.
K241123	Perpak Sterilization Tyvek Pouch	Sep 18, 2024	Substantially Equivalent	KM Corp.
K234132	Medline Reusable Sterilization Wrappers	Sep 17, 2024	Substantially Equivalent	Medline Industries, LP
K234050	HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap	Sep 16, 2024	Substantially Equivalent	O&M Halyard, Inc.
K240330	HALYARD* SMART-FOLD* Sterilization Wrap (H450); HALYARD* SMART-FOLD* Sterilization Wrap (H650)	Aug 07, 2024	Substantially Equivalent	O&M Halyard, Inc.
K240862	Medicom Sterilization Wrap	Jun 21, 2024	Substantially Equivalent	Medicom Group, Inc
K232625	Steriking® Pouch for Robotic Instruments	Jun 07, 2024	Substantially Equivalent	Wipak OY
K233777	PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)	May 24, 2024	Substantially Equivalent	PRIMED Medical Products Inc.
K233262	Dukal SMS Sterilization Wrap	Mar 22, 2024	Substantially Equivalent	Dukal LLC
K230137	Reliance® Fusion Sterilization Wraps	Dec 07, 2023	Substantially Equivalent	Ahlstrom-Munksjo Nonwovens LLC
K231999	Steriking® LT-Blueline Pouches with Tyvek®	Sep 07, 2023	Substantially Equivalent	Wipak OY
K231996	Steriking® LT-Blueline Pouches with Tyvek®	Sep 07, 2023	Substantially Equivalent	Wipak OY
K223600	Sterilization Wrap	Aug 25, 2023	Substantially Equivalent	Wuhan Zonsen Medical Products Co., Ltd.
K231500	Vis-U-All Low Temperature Sterilization Pouches	Aug 07, 2023	Substantially Equivalent	Steris Corporation
K223025	Tyvek Roll with CI for STERLINK Sterilizer	May 09, 2023	Substantially Equivalent	Plasmapp Co., Ltd.
K222151	Sterilization Wrap	Mar 23, 2023	Substantially Equivalent	Kenpax International Limited
K221875	Sterilization Pouch and Roll	Feb 13, 2023	Substantially Equivalent	Qianjiang Kingphar Medical Packaging & Printing Co., Ltd.
K221379	Steriking LT-Blueline Pouches with Tyvek	Jan 04, 2023	Substantially Equivalent	Wipak OY
K221377	SteriKing LT-Blueline Pouches with Tyvek	Dec 22, 2022	Substantially Equivalent	Wipak OY
K220365	Gemini Sterilization Wrap	Oct 06, 2022	Substantially Equivalent	Medline Industries, LP
K222440	Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays	Sep 09, 2022	Substantially Equivalent	Steris
K191131	Solidence Multipockets	Aug 03, 2022	Substantially Equivalent	Solidence Surgical Corporation
K214007	HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap	Jul 27, 2022	Substantially Equivalent	Owens & Minor (O&M) Halyard, Inc.
K221016	Steriking Packaging for Medical Devices	May 05, 2022	Substantially Equivalent	Wipak OY
K213907	CareGUARD Sterilization Wrap	Mar 14, 2022	Substantially Equivalent	Care Essentials Pty Ltd
K220133	Sterilization Wraps	Mar 10, 2022	Substantially Equivalent	Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
K210810	Steiking Packaging for Medical Devices	Jan 23, 2022	Substantially Equivalent	Wipak OY
K212338	SterileRight sterilization pouch and roll	Nov 01, 2021	Substantially Equivalent	SterileRight Packaging Mfg., Inc.
K212198	Tyvek(R) Roll with CI for STERLINKTM Sterilizer	Oct 22, 2021	Substantially Equivalent	Plasmapp Co,.Ltd.
K202593	Turbett Instrument Pod	May 19, 2021	Substantially Equivalent	Turbett Surgical Inc.
K202462	SIGMA Sterilization Pouch and Roll	Apr 23, 2021	Substantially Equivalent	Sigma Medical Supplies Corporation
K200336	Tyvek Sterilization Pouches with Chevron Seal	Nov 12, 2020	Substantially Equivalent	Andersen Sterilizers, Inc.
K200335	Sterisheet Sterilization Wrap	Nov 12, 2020	Substantially Equivalent	Andersen Sterilizers, Inc.
K200240	Turbett Instrument Pod	Apr 30, 2020	Substantially Equivalent	Turbett Surgical Inc.
K193561	Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch	Apr 15, 2020	Substantially Equivalent	Weihai Xingtai Packaging Products Co.,Ltd.
K192641	Gemini Titan Sterilization Wrap	Jan 24, 2020	Substantially Equivalent	Medline Industries, Inc.
K192147	Halyard ONE-STEP* Sterilization Wrap	Oct 10, 2019	Substantially Equivalent	Owens & Minor (O&M) Halyard, Inc
K182184	Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)	Oct 10, 2019	Substantially Equivalent	MDK (ShangHai) Medical Packing Co., Ltd.
K183356	Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch	Aug 19, 2019	Substantially Equivalent	Weihai Xingtai Packaging Products Co.,Ltd.
K181957	Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted	Jul 09, 2019	Substantially Equivalent	Tianchang Jiarui Packaging Material Co., Ltd.
K182656	JAMBRO Single Core A Sterilization wrap	Jun 11, 2019	Substantially Equivalent	Jiangsu Zhande Medical Supplies Co., Ltd
K181959	HALYARD SMART-FOLD* Sterilization Wrap (H450, H650)	Mar 22, 2019	Substantially Equivalent	Owens& Minor Halyard, Inc.
K183401	Vis-U-All Low Temperature Sterilization Pouch/Tubing	Mar 01, 2019	Substantially Equivalent	STERIS Corporation
K183297	Vis-U-All Low Temperature Sterilization Pouch/Tubing	Jan 03, 2019	Substantially Equivalent	STERIS Corporation
K180139	Safe Secure Sterilization Pouches and Rolls	Jan 03, 2019	Substantially Equivalent	Safe Secure Packing Co., Ltd.
K181174	Cardinal Health Sterilization Wrap	Dec 11, 2018	Substantially Equivalent	Cardinal Health 200 LLC
K172280	BH Sterilization Pouch	Aug 03, 2018	Substantially Equivalent	BH Medical Products Co., Ltd.
K180672	Sterilization Pouch/Roll Made with Tyvek	Jun 06, 2018	Substantially Equivalent	Sigma Medical Supplies Corporation
K180661	SIGMA Sterilization Pouch and Roll	Jun 05, 2018	Substantially Equivalent	Sigma Medical Supplies Corp.
K172749	Vis-U-All Low Temperature Sterilization Pouch/Tubing	Feb 09, 2018	Substantially Equivalent	Steris Corporation
K170437	Sterisheet Sterilization Wrap	Nov 01, 2017	Substantially Equivalent	Andersen Sterilizers,Inc.
K170429	Tyvek Sterilization Pouches with Chevron Seal	Oct 27, 2017	Substantially Equivalent	Andersen Sterilizers, Inc.
K162362	PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator	Oct 13, 2017	Substantially Equivalent	PMS TIBBI CIHAZLAR TEKNOLOJISI SAN VE TIC AS
K172207	Standard Supreme Sterilization Wrapper	Aug 25, 2017	Substantially Equivalent	Standard Textile Co., Inc.
K171533	Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap	Jun 29, 2017	Substantially Equivalent	Ahlstrom Nonwovens LLC
K162993	Gemini Sterilization Wrap	Jun 23, 2017	Substantially Equivalent	Medline Industries, Inc.
K162258	Self Sealing Sterilization Pouches	Apr 28, 2017	Substantially Equivalent	Tianchang Jiarui Packaging Material Co., Ltd.
K161910	Cardinal Health Sterilization Wrap	Apr 20, 2017	Substantially Equivalent	CARDINAL HEALTH 200, LLC
K161415	SteriTite Containers System & MediTray Products	Feb 10, 2017	Substantially Equivalent	CASE MEDICAL, INC.
K160595	PMSSteripack Tyvek Sterilization Pouch (TP) and Roll (TY) with Chemical Indicator	Nov 18, 2016	Substantially Equivalent	PMS Medikal Ambalaj Sanayi ve Ticaret LTD STI
K162162	Barrier Supreme Sterilization Wrapper	Nov 04, 2016	Substantially Equivalent	Standard Textile Co., Inc.
K153540	Safe Secure Sterilization Pouch with Steam and Ethylene Oxide Process Indicators	Aug 04, 2016	Substantially Equivalent	SAFE SECURE PACKAGING CO., LTD
K160755	Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap	Jul 27, 2016	Substantially Equivalent	AHLSTROM NONWOVENS LLC
K160908	Vis-U-All Low Temperature Sterilization Pouch/Tubing	Jul 22, 2016	Substantially Equivalent	STERIS CORPORATION
K152564	Gemini Sterilization Wrap	Jul 07, 2016	Substantially Equivalent	MEDLINE INDUSTRIES, INC.
K152458	Gemini Bonded Sterilization Wrap	Jun 01, 2016	Substantially Equivalent	MEDLINE INDUSTRIES, INC.
K152669	PMSSteripack Self-Seal Sterilization Pouch with Chemical Indicator (KP)	Jan 15, 2016	Substantially Equivalent	PMS TIP TEKNOLOJILERI SANAYI VE TICARET LIMITED STD
K153025	Turbett Surgical Container	Jan 14, 2016	Substantially Equivalent	TURBETT SURGICAL LLC
K151445	Cardinal Health Sterilization Wrap	Dec 21, 2015	Substantially Equivalent	CARDINAL HEALTH 200, LLC
K152291	Sterisheet Sterilization Wrap	Dec 17, 2015	Substantially Equivalent	ANDERSEN STERILIZERS, INC.
K150698	Gemini Sterilization Wrap	Nov 20, 2015	Substantially Equivalent	MEDLINE INDUSTRIES, INC.
K152058	Tyvek Sterilization Pouches with Chevron Seal	Nov 18, 2015	Substantially Equivalent	Andersen Sterilizers,Inc.
K151788	Cardinal Health Sterilization Wrap	Oct 30, 2015	Substantially Equivalent	Cardinal Health 200, LLC
K143117	Wire Sterilization Package with Indicators	Oct 29, 2015	Substantially Equivalent	AMERICAN ORTHODONTICS
K143637	U&U Sterilization Pouch and Roll	Sep 09, 2015	Substantially Equivalent	U&U Medical Technology Co.,Ltd
K143147	Gemini Bonded Sterilization Wrap	May 07, 2015	Substantially Equivalent	MEDLINE INDUSTRIES, INC.
K143053	KIMGUARD ONE-STEP Sterilization Wrap	Apr 03, 2015	Substantially Equivalent	KIMBERLY-CLARK HEALTH CARE
K141826	FLASHPAK STERILIZATION CONTAINER SYSTEM	Apr 02, 2015	Substantially Equivalent	SYMMETRY MEDICAL INC- MANCHESTER
K133838	STERILIZATION POUCH/ROLL MADE WITH TYVEK	Mar 11, 2015	Substantially Equivalent	SIGMA MEDICAL SUPPLIES CORP.
K142782	KIMGUARD ONE-STEP Sterilization Wrap	Mar 09, 2015	Substantially Equivalent	Kimberly-Clark Health Care
K141693	Tyvek® Pouch/Roll with STERRAD® Chemical Indicator	Dec 19, 2014	Substantially Equivalent	ADVANCED STERILIZATION PRODUCTS
K141712	KIMGUARD ONE STEP STERILIZATION WRAP	Dec 18, 2014	Substantially Equivalent	Halyard Health
K141412	STERILUCENT SELF-SEAL STERILIZATION POUCH	Dec 03, 2014	Substantially Equivalent	GS MEDICAL PACKAGING, INC.
K140963	KIMGUARD SMART-FOLD STERILIZATION WRAP	Nov 10, 2014	Substantially Equivalent	KIMBERLY-CLARK CORP.
K141612	KIMGUARD ONE-STEP STERILIZATION WRAP	Aug 07, 2014	Substantially Equivalent	KIMBERLY-CLARK HEALTH CARE
K141071	KIMGUARD ONE-STEP STERILIZATION WRAP	Jul 28, 2014	Substantially Equivalent	KIMBERLY-CLARK HEALTH CARE
K140487	VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING	Jul 22, 2014	Substantially Equivalent	STERIS Corporation
K123162	U&U HYDROGEN PEROXIDE GAS PLASMA STERILIZATION POUCH/ROLL	Feb 26, 2014	Substantially Equivalent	U&U MEDICAL TECHNOLOGY CO., LTD
K132060	DURABLUE STERILIZATION WRAP	Dec 13, 2013	Substantially Equivalent	CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES
K113806	KIMGUARD ONE STEP STERILIZATION WRAP	Aug 20, 2013	Substantially Equivalent	KIMBERLY-CLARK HEALTH CARE
K130927	DURABLUE STERILIZATION WRAP	Jun 18, 2013	Substantially Equivalent	CARDINAL HEALTH 200, LLC
K123289	DURABLUE STERILIZATION WRAP	Feb 28, 2013	Substantially Equivalent	CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES
K113353	GEMINI STERILZATION WRAP	Jan 31, 2013	Substantially Equivalent	MEDLINE INDUSTRIES, INC.
K123857	DURABLUE STERILIZATION WRAP	Jan 23, 2013	Substantially Equivalent	CARDINAL HEALTH 200, LLC
K122507	DURABLUE STERILIZATION WRAP, MODEL NUMBERS CH100, CH200, CH300, CH400, CH500 AND CH600, STERRAD NX STERILIZATION	Sep 26, 2012	Substantially Equivalent	CARDINAL HEALTH 200, LLC
K110954	ARJORAD STERILE WRAP	Aug 24, 2012	Substantially Equivalent	ARJO WIGGINS MEDICAL, INC.
K113776	FLASHPAK	Aug 08, 2012	Substantially Equivalent	SYMMETRY MEDICAL
K112805	KIMGUARD ONE-STEP STERILIZATION WRAP	Jun 22, 2012	Substantially Equivalent	KIMBERLY-CLARK CORP.
K120658	DURABLUE STERILIZATION WRAP	Jun 13, 2012	Substantially Equivalent	CARDINAL HEALTH 200, LLC
K120542	CARDINAL HEALTH DURABLUE STERILIZATION WRAP	Jun 01, 2012	Substantially Equivalent	CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES
K112591	SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS	Feb 07, 2012	Substantially Equivalent	SAFE SECURE PACKAGING CO., LTD
K112904	STERITEC CONTAINERS SYSTEM & MEDITRAY PRODUCTS	Jan 24, 2012	Substantially Equivalent	CASE MEDICAL, INC.
K112918	DURABLUE STERILIZATION (AMSCO V-PRO) WRAP	Jan 20, 2012	Substantially Equivalent	CARDINAL HEALTH 200, LLC
K112300	KIMGUARD SMART-FOLD* STERILIZATION WRAP	Jan 19, 2012	Substantially Equivalent	KIMBERLY-CLARK CORP.
K112283	DURA BLUE STERILIZATION WRAP	Oct 20, 2011	Substantially Equivalent	CARDINAL HEALTH 200, LLC
K112211	DURA BLUE STERILIZATION WRAP	Oct 20, 2011	Substantially Equivalent	CARDINAL HEALTH 200, LLC
K102158	SIGMA STERILIZATION POUCH & ROLL	Aug 02, 2011	Substantially Equivalent	SIGMA MEDICAL SUPPLIES CORP.
K110867	STERI-DENT, STERI-SURE	Jul 20, 2011	Substantially Equivalent	CPAC, INC.
K103210	TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORS	Jun 06, 2011	Substantially Equivalent	ADVANCED STERILIZATION PRODUCTS
K102864	84E SERIES SINGLE PLY WRAPPER	Jan 14, 2011	Substantially Equivalent	LAC MAC, LTD.
K102783	HINSON & HALE MEDICAL TECHNOLOGIES INFUSED (R) POLYESTER WRAPPERS	Dec 22, 2010	Substantially Equivalent	HINSON AND HALE MEDICAL TECHNOLOGIES, INC
K093493	AESCULAP STERILCONTAINER S	Jul 27, 2010	Substantially Equivalent	AESCULAP, INC.
K093649	AESCULAP STERILCONTAINER S	May 11, 2010	Substantially Equivalent	AESCULAP
K090068	STERITITE UNIVERSAL CONTAINER SYSTEM AND MEDITRAY PRODUCTS	Feb 24, 2010	Substantially Equivalent	CASE MEDICAL, INC.
K092167	KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600	Nov 02, 2009	Substantially Equivalent	KIMBERLY-CLARK CORP.
K091685	KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC 500, KC600	Sep 03, 2009	Substantially Equivalent	KIMBERLY-CLARK CORP.
K082554	KIMGUARD STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500 AND KC600	May 01, 2009	Substantially Equivalent	KIMBERLY-CLARK CORP.
K082177	KIMGUARD ONE-STEP STERILIZATION WRAP	Mar 27, 2009	Substantially Equivalent	KIMBERLY-CLARK CORP.
K080558	STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS	Dec 05, 2008	Substantially Equivalent	CASE MEDICAL, INC.
K080198	TSO3 OZONE STERILIZATION WRAP	May 30, 2008	Substantially Equivalent	TSO3 INC.
K071886	SELF SEAL STERILIZATION POUCH	Dec 27, 2007	Substantially Equivalent	SHANGHAI JIANZHONG MEDICAL PACKAGING CO., LTD.
K071087	VIS-U-ALL II HEAT-SEAL POUCH AND TUBING	Oct 16, 2007	Substantially Equivalent	STERIS Corporation
K062704	STERILIZATION POUCH WITH INDICATORS	Jun 08, 2007	Substantially Equivalent	WINNER INDUSTRIES (SHENZHEN) CO., LTD.
K062100	ARJOWRAP 47/100 AND 47/88	Dec 05, 2006	Substantially Equivalent	ARJO WIGGINS MEDICAL, INC.
K062510	AESCULAP STERILCONTAINER SYSTEM	Nov 17, 2006	Substantially Equivalent	AESCULAP
K052992	CONMED LINVATEC INSTRUMENT STERILIZATION TRAY	Oct 16, 2006	Substantially Equivalent	CONMED LINVATEC
K052665	GRANTON MEDICAL 121-135 C SELF-SEAL STERILIZATION POUCHES	Feb 27, 2006	Substantially Equivalent	GRANTON MEDICAL LTD.
K053389	AESCULAP STERILCONTAINER SYSTEM	Feb 15, 2006	Substantially Equivalent	AESCULAP, INC.
K041096	WAGNER STERISET STERILIZATION CONTAINER	Jun 03, 2005	Substantially Equivalent	WAGNER GMBH
K041623	REUSABLE STERILCONTAINER FILTER MODEL #JK090	Dec 13, 2004	Substantially Equivalent	AESCULAP, INC.
K040865	AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER	Dec 06, 2004	Substantially Equivalent	AESCULAP
K042580	TIDI BRAND STERILIZATION WRAP	Nov 17, 2004	Substantially Equivalent	BANTA HEALTHCARE GROUP, LTD.
K040707	PACKAGING TRAY AND COMPONENTS	Apr 16, 2004	Substantially Equivalent	VYGON US LLC
K022978	STERITITE CONTAINER WITH FLASHTITE VALVE PLATE(S) & MEDITRAY PRODUCTS	May 09, 2003	Substantially Equivalent	CASE MEDICAL, INC.
K031022	PROTEC-TOP, STERIDENT, BENTO	Apr 14, 2003	Substantially Equivalent	RONPAK, INC.
K023614	STERITITE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM	Apr 07, 2003	Substantially Equivalent	CASE MEDICAL, INC.
K023658	STERILIZATION CASES AND TRAYS	Mar 25, 2003	Substantially Equivalent	CARR METAL PRODUCTS, INC.
K030853	STERITITE PERFORATED BASE RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02-POLYPROPYLENE NON-WOVEN DISPOSABLE FI	Mar 21, 2003	Substantially Equivalent	CASE MEDICAL, INC.
K023025	SELF SEAL STERILIZATION POUCH	Mar 04, 2003	Substantially Equivalent	GRANTON MEDICAL LTD.
K013003	APTIMAX INSTRUMENT TRAY, INSTRUMENT MAT AND INSTRUMENT HOLDER	Aug 28, 2002	Substantially Equivalent	ADVANCED STERILIZATION PRODUCTS
K012931	GENESIS STERRAD COMPATIBLE REUSABLE STERILIZATION CONTAINER SYSTEM	Aug 20, 2002	Substantially Equivalent	ALLEGIANCE HEALTHCARE CORP.
K013715	RE-USABLE STERILIZATION POUCH / BAG	Apr 01, 2002	Substantially Equivalent	QUALITY PRODUCTS OF MONTANA
K993535	METAPAK MULTI-PURPOSE INSTRUMENT TRAY	Dec 07, 2001	Substantially Equivalent	RILEY MEDICAL, INC.
K010825	MEDLINE STERISET STERILIZATION CONTAINER	May 08, 2001	Substantially Equivalent	MEDLINE
K002968	MEDLINE STERILIZATION WRAP	Jan 23, 2001	Substantially Equivalent	MEDLINE INDUSTRIES, INC.
K983299	ALLEGIANCE GENESIS CONTAINER SYSTEM	Aug 04, 2000	Substantially Equivalent	ALLEGIANCE HEALTHCARE CORP.
K993871	BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP	Apr 21, 2000	Substantially Equivalent	ALLEGIANCE HEALTHCARE CORP.
K991023	STERITITE PERFORATED BOTTOM RIGID REUSABLE STERILIZATION CONTAINER SYSTEM WITH SCF02 - POLYPROPYLENE NON-WOVEN DISPOSABL	Jan 27, 2000	Substantially Equivalent	CASE MEDICAL, INC.
K993835	PARAPOST SYSTEM STERILIZABLE ORGANIZER	Dec 16, 1999	Substantially Equivalent	COLTENE/WHALEDENT INC.
K993255	BIOSONIC UC-70 STERILIZABLE INSTRUMENT CASSETTE	Dec 06, 1999	Substantially Equivalent	COLTENE/WHALEDENT INC.
K983719	BIOSHIELD EXPRESS STERILIZATION WRAP	Aug 25, 1999	Substantially Equivalent	ALLEGIANCE HEALTHCARE CORP.
K990761	TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE	Jul 09, 1999	Substantially Equivalent	TUTTNAUER USA CO. LTD.
K990567	GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH	Apr 05, 1999	Substantially Equivalent	GLOBAL HEALTHCARE, INC.
K990300	SUPRASHIELD EXPRESS STERILIZATION WRAP	Feb 10, 1999	Substantially Equivalent	ALLEGIANCE HEALTHCARE CORP.
K983223	DENTAL STERLIZATION TRAY/CASSETTE	Jan 14, 1999	Substantially Equivalent	BRASSELER USA I, L.P.
K974638	STERITITE SEALED CONTAINERS MODEL SCO4Q	Dec 18, 1997	Substantially Equivalent	CASE MEDICAL, INC.
K972138	CARR RIGID CONTAINER SYSTEM	Nov 13, 1997	Substantially Equivalent	CARR METAL PRODUCTS, INC.
K971483	SECURE-WRAP (TM) STERILIZATION WRAP	Jun 24, 1997	Substantially Equivalent	AMERICAN THRESHOLD INDUSTRIES, INC.
K964256	CYGNUS INSTRUMENT PROTECTORS	May 06, 1997	Substantially Equivalent	MADISON POLYMERIC ENGINEERING
K962605	PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE)	Mar 11, 1997	Substantially Equivalent	SURGICOT, INC.
K970152	BIOPSY TRAY	Mar 05, 1997	Substantially Equivalent for Some Indications	MEDCARE MEDICAL GROUP, INC.
K961227	JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY	Jun 10, 1996	Substantially Equivalent	J.J. SKINNER, INC.
K960213	CPR TOTAL HIP PACK	Apr 12, 1996	Substantially Equivalent	CUSTOM PACK RELIABILITY
K960211	CPR TOTAL KNEE PACK	Apr 12, 1996	Substantially Equivalent	CUSTOM PACK RELIABILITY
K960210	CPR ORTHO HAND PACK	Apr 12, 1996	Substantially Equivalent	CUSTOM PACK RELIABILITY
K960206	CPR DRESSING CHANGE TRAY	Apr 12, 1996	Substantially Equivalent	CUSTOM PACK RELIABILITY
K960238	CPR SUTURE REMOVAL KIT	Mar 28, 1996	Substantially Equivalent	CUSTOM PACK RELIABILITY
K960208	CPR BASIC SET-UP TRAY	Mar 28, 1996	Substantially Equivalent	CUSTOM PACK RELIABILITY
K960520	LACERATION TRAY	Mar 21, 1996	Substantially Equivalent	MEDCO INSTRUMENTS, INC.
K960207	CPR LACERATION TRAY	Feb 27, 1996	Substantially Equivalent	CUSTOM PACK RELIABILITY
K960204	G.E. STERILE, PERCUTANEOUS CHOLANGIOGRAPHIC TRAY	Feb 27, 1996	Substantially Equivalent	GE MEDICAL SYSTEMS
K960202	G.E. STERILE PUNCTURE TRAY	Feb 21, 1996	Substantially Equivalent	GE MEDICAL SYSTEMS
K960201	G.E. STERILE BREAST BIOPSY/LOCALIZATION TRAY	Feb 21, 1996	Substantially Equivalent	GE MEDICAL SYSTEMS
K960141	G.E. STERILE, STANDARD BIOPSY TRAY	Feb 21, 1996	Substantially Equivalent	GE MEDICAL SYSTEMS
K955688	RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY	Feb 21, 1996	Substantially Equivalent	CONTOUR FABRICATORS OF FLORIDA, INC.
K955686	RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY	Feb 21, 1996	Substantially Equivalent	CONTOUR FABRICATORS OF FLORIDA, INC.
K955678	RNS STERILE DISPOSABLE PUNCTURE TRAY	Feb 21, 1996	Substantially Equivalent	CONTOUR FABRICATORS OF FLORIDA, INC.
K955658	LACERATION TRAY	Jan 25, 1996	Substantially Equivalent	TRANSIDYNE GENERAL CORP.
K953678	STERIMED STERIZATION WRAPPER (NON-STERILE)	Oct 02, 1995	Substantially Equivalent	CUSTOMED, INC.
K951704	NON-WOVEN FILTER PAPER FOR STEAM AND GAS STERILIZATION	Jun 28, 1995	Substantially Equivalent	PRODUCTS FOR MEDICINE
K946019	SURGICLA INSTRUMENT KIT	Mar 20, 1995	Substantially Equivalent	MEDICAL ACTION INDUSTRIES, INC.
K950438	SAFEDWEEL DRESSING CHANGE TRAY	Mar 15, 1995	Unknown	BECTON DICKINSON VASCULAR ACCESS, INC.
K950850	GENT-L-KARE LACERATION TRAYS	Mar 14, 1995	Substantially Equivalent for Some Indications	PREMIUM PLASTICS, INC.
K943653	MAMMOCORE BIOPSY TRAY	Jan 30, 1995	Unknown	MANAN MEDICAL PRODUCTS, INC.
K944881	SKIN SCRUB TRAY	Dec 27, 1994	Unknown	CLINICAL RESOURCES, INC.
K944854	STERISURE STERILIZATION WRAP	Dec 19, 1994	Substantially Equivalent	FIBERWEB NORTH AMERICA, INC.
K943090	SUTURE REMOVAL TRAYS	Aug 22, 1994	Unknown	STERILE CONCEPTS, INC.
K941645	BIOPSY TRAY	Jul 14, 1994	Unknown	CUSH MEDICAL PRODUCTS
K931875	AUTOCLAVABLE REUSABLE WRAP -- CENTERAL SERVICE USE	Jun 10, 1994	Substantially Equivalent	AMSCO STERILE RECOVERIES, INC.
K931874	RECOVERIES AUTOCLAVABLE RESUABLE WRAP -- FAC. USE	Jun 10, 1994	Substantially Equivalent	AMSCO STERILE RECOVERIES, INC.
K941542	ORION CENTRAL LINE DRESSING CHANGE TRAY	May 23, 1994	Unknown	REGULATORY & MARKETING SERVICES, INC.
K942000	BURN DRESSING TRAY	May 20, 1994	Unknown	MEDCARE CUSTOM PACKAGING, INC.
K941471	CENTRAL LINE DRESSING CHANGE TRAY	May 12, 1994	Substantially Equivalent	CLINICAL RESOURCES, INC.
K941468	DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY	May 12, 1994	Substantially Equivalent	CLINICAL RESOURCES, INC.
K941467	WOUND DRESSING KIT	May 12, 1994	Substantially Equivalent	CLINICAL RESOURCES, INC.
K941466	SURGICAL INSTRUMENTS KIT	Apr 22, 1994	Unknown	CLINICAL RESOURCES, INC.
K933550	HYDRASPUN M STERILIZATION WRAP	Mar 29, 1994	Substantially Equivalent	AHLSTROM DEXTER
K934031	STERILE CENTRAL LINE DRESSING TRAY	Mar 01, 1994	Unknown	SURGIPRO, INC.
K935238	ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAY	Feb 17, 1994	Unknown	SHERWOOD MEDICAL CO.
K935742	SKIN SCRUB TRAY	Feb 10, 1994	Substantially Equivalent	CUSH MEDICAL PRODUCTS
K935685	TRACHEOSTOMY CARE TRAY	Feb 10, 1994	Substantially Equivalent	CUSH MEDICAL PRODUCTS
K935683	SUTURE REMOVAL TRAY	Feb 10, 1994	Substantially Equivalent	CUSH MEDICAL PRODUCTS
K935682	LACERATION TRAY	Feb 10, 1994	Substantially Equivalent	CUSH MEDICAL PRODUCTS
K935681	INCISION/DRAINAGE TRAY	Feb 10, 1994	Substantially Equivalent	CUSH MEDICAL PRODUCTS
K935622	CUSTOM PLASTIC PACKS	Feb 07, 1994	Substantially Equivalent	ASSOCIATED MEDICAL
K931669	CARAPACE DEBRIDEMENT KITS	Feb 07, 1994	Unknown	CARAPACE, INC.
K931202	STERILIZATION WRAP-STERISHEET	Dec 16, 1993	Substantially Equivalent	ARJO WIGGINS MEDICAL, INC.
K933151	CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM	Dec 13, 1993	Unknown	CONTOUR FABRICATORS OF FLORIDA, INC.
K932036	LACERATION TRAY	Dec 13, 1993	Unknown	CLINIPAD CORP.
K923408	WRAPPEL T	Apr 08, 1993	Substantially Equivalent	STANDARD TEXTILE CO., INC.
K922845	BASIC DRESSING CHANGE TRAY SMP 102A	Dec 29, 1992	Unknown	SPECIALTY MEDICAL PRODUCTS CO.
K921243	CONVERTORS STERILIZATION WRAP	Oct 28, 1992	Substantially Equivalent	BAXTER HEALTHCARE CORP.
K920480	DRESSING CHANG & WOUND MANAGEMENT	Oct 19, 1992	Unknown	CYPRESS MEDICAL PRODUCTS, LTD.
K921490	DRESSING CHANGE TRAY DECUBITUS ULCER/STERILE-DISP	Oct 05, 1992	Unknown	TRINITY LABORATORIES, INC.
K920339	DRESSING CHANGE TRAY	Apr 23, 1992	Unknown	MEDIKMARK, INC.
K914932	SUTURE REMOVAL KIT	Jan 31, 1992	Unknown	WESTMARK HOSPITAL SUPPLIES
K911760	MONARCH STERILIZATION CONTAINER SYST, MODIFICATION	Jun 24, 1991	Substantially Equivalent	MONARCH PRODUCTS, INC.
K894437	PEEL-VUE AUTOCLAVE/CHEMICALVE POUCH	Jan 10, 1990	Substantially Equivalent	CLIVE CRAIG CO.
K893764	STERILIZATION TRAY LINER	Aug 15, 1989	Substantially Equivalent	AHLSTROM DEXTER
K885019	BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI.	Jan 25, 1989	Substantially Equivalent	BEMIS HEALTH CARE
K883802	CARETEX CENTRAL SUPPLY WRAP	Oct 21, 1988	Substantially Equivalent	JAMES RIVER CORP.
K883376	STERILIZATION WRAP TYPE 22,44,77	Sep 28, 1988	Substantially Equivalent	EAST TEXAS LIGHTHOUSE FOR THE BLIND
K881471	KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP	Aug 10, 1988	Substantially Equivalent	KIMBERLY-CLARK CORP.
K873175	CENTRAL SUPPLY ROOM WRAP	Sep 09, 1987	Substantially Equivalent	ULTI-MED INTL., INC.
K872754	HEALTH-PAK/WYCOMBE CSR WRAP	Aug 06, 1987	Substantially Equivalent	HEALTH-PAK, INC.
K871798	FILM AND PAPER COMBINATION STERILIZING BAG	Jul 21, 1987	Substantially Equivalent	COST RITE HEALTH PRODUCTS, INC.
K871202	FLASHPAK CONTAINER SYSTEM	May 29, 1987	Substantially Equivalent	PERFORMANCE INSTRUMENTS CORP.
K870147	CARERITE & COST RITE NYLON STERILIZATION FILM	Apr 23, 1987	Substantially Equivalent	COST RITE HEALTH PRODUCTS, INC.
K863981	STERILIZATION WRAPS #620,624,648,640,636,630,612	Nov 25, 1986	Substantially Equivalent	GRAHAM MEDICAL PRODUCTS
K862241	STANDARD BASIN KIT CUSTOM BASIN KIT	Aug 01, 1986	Substantially Equivalent	QUALI-MED, INC.
K852335	STERILIZATION CONTAINER	Sep 16, 1985	Substantially Equivalent	BEMIS MFG. CO.
K850289	MONARCH STERILIZATION CONTAINER SYSTEM	Aug 15, 1985	Substantially Equivalent	MONARCH PRODUCTS, INC.
K852203	KIMGUARD PROCEDURE TRAY	Jun 07, 1985	Substantially Equivalent	KIMBERLY-CLARK CORP.
K851315	ABCO INSTRUMENT PACKS & TRAYS	May 01, 1985	Substantially Equivalent	ABCO DEALERS, INC.
K851340	BLUE SEAL II STERILIZATION POUCH	Apr 24, 1985	Substantially Equivalent	AMERICAN STERILIZER CO.
K844920	CSR WRAP - CENTRAL SUPPLY ROOM WRAP FOR STERIL-	Apr 01, 1985	Substantially Equivalent	PAPETERIES DEPONT-AUDEMER
K844672	INSTRUTAINER	Feb 22, 1985	Substantially Equivalent	INTRUMED, INC.
K844611	SINGLE BASIN SET	Dec 19, 1984	Substantially Equivalent	PACKAGING TECHNOLOGIES, INC.
K842644	TPN/HYPERALIMENTATION TRAY	Nov 08, 1984	Substantially Equivalent	DEROYAL INDUSTRIES, INC.
K843982	O.B. BASIN SET	Oct 31, 1984	Substantially Equivalent	PRO-LAB, INC.
K842490	SKIN SCRUB TRAY STERILE SKIN SCRUB KIT	Aug 17, 1984	Substantially Equivalent	BIOLOGICAL & ENVIRONMENTAL CONTROL LABORATORIES
K842405	DR. GOULD HAND PACK SUSTOM STERIL	Aug 15, 1984	Substantially Equivalent	PRO-LAB, INC.
K842136	STERILE PAN SET	Jul 06, 1984	Substantially Equivalent	MEDI-PLAST INTL., INC.
K841484	STERILE O.R. BASIN KIT PRODUCT LINE	Jul 02, 1984	Substantially Equivalent	MEDLINE INDUSTRIES, INC.
K841123	DRESSING CHANGE TRAY	Apr 17, 1984	Substantially Equivalent	MEDCARE PRODUCTS
K841156	VANTAGE E	Apr 13, 1984	Substantially Equivalent	AMERICAN STERILIZER CO.
K840342	PDI PREPMASTER WET PACK PATIENT PREP KIT	Mar 27, 1984	Substantially Equivalent	NICE-PAK PRODUCTS, INC.
K840344	PDI PREPMASTER WET PACK MINOR PROCEDURE	Mar 26, 1984	Substantially Equivalent	NICE-PAK PRODUCTS, INC.
K840595	E-Z OPEN DUST COVERS	Mar 19, 1984	Substantially Equivalent	PLASTI-PRODUCTS, INC.
K834193	JAKOBI SURG. INSTRUMENTS #2 70/71	Feb 10, 1984	Substantially Equivalent	IMM ENTERPRISES LTD.
K833343	STERILIZATION CONTAINER	Nov 03, 1983	Substantially Equivalent	MEDIN CORP.
K831425	MDT CHEMITEST SEE-THRU BAG	Jun 02, 1983	Substantially Equivalent	KENPAK CONVERTERS, INC.
K830476	OR PREP KIT	Mar 31, 1983	Substantially Equivalent	CLINIPAD CORP.
K830739	PRO-GUARD	Mar 29, 1983	Substantially Equivalent	SURGICOT, INC.
K830540	RENNCO MODEL LS LIFT SEAL HEAT SEALER	Mar 17, 1983	Substantially Equivalent	RENNCO, INC.
K830281	SKIN SCRUB PREP. TRAY	Mar 11, 1983	Substantially Equivalent	ZOA, INC.
K823902	EAGLE STERISET	Jan 09, 1983	Substantially Equivalent	AMERICAN STERILIZER CO.
K823513	CENTRAL SUPPLY ROOM WRAP	Jan 07, 1983	Substantially Equivalent	JAMES RIVER CORP.
K823223	VIEW-PACK & MULTI POUCH	Nov 22, 1982	Substantially Equivalent	SBW MEDICAL PACKAGING, INC.
K822931	SCR WRAP	Oct 26, 1982	Substantially Equivalent	FOX CONVERTING, INC.
K822482	SURGILITE NON-WOVEN WRAP	Sep 21, 1982	Substantially Equivalent	SURGILITE INTL., INC.
K822211	STERILE HD PAN SET	Aug 16, 1982	Substantially Equivalent	HOSPITAL DISPOSABLES, INC.
K821044	PATIENT PREP KITS/TRAYS-STERILE	Jun 23, 1982	Substantially Equivalent	PHOENIX GLOVE CO.
K821331	MEDI-SEAL STERILIZATION POUCHES & TUB	Jun 07, 1982	Substantially Equivalent	MEDICAL INDUSTRIES PACKAGING, INC.
K821330	GAS STERILIZATION POUCHES	Jun 07, 1982	Substantially Equivalent	MEDICAL INDUSTRIES PACKAGING, INC.
K821482	STERILE HD PAN SET	Jun 02, 1982	Substantially Equivalent	HOSPITAL DISPOSABLES, INC.
K820689	C.S.R. WRAPPERS	Apr 09, 1982	Substantially Equivalent	GENERAL MEDICAL CO.
K820589	ECONOMY LINE OF TRAYS	Apr 09, 1982	Substantially Equivalent	ABCO DEALERS, INC.
K820521	STERILIZATION WRAP	Mar 18, 1982	Substantially Equivalent	GENERAL MEDICAL CO.
K820171	SUBCLAVIAN INSERTION KIT	Mar 02, 1982	Substantially Equivalent	CLINIPAD CORP.
K820302	SURGIPEEL SELF-SEAL PACKAGING SYSTEM	Feb 24, 1982	Substantially Equivalent	SURGICOT, INC.
K813437	PAN SET	Dec 31, 1981	Substantially Equivalent	STERILE DESIGN, INC.
K811819	BOUNDARY STERILIZATION WRAP	Aug 04, 1981	Substantially Equivalent	THE BUCKEYE CELLULOSE CORP.
K811670	STERI-LOK DUAL PURPOSE PACKAGING/8400	Jul 10, 1981	Substantially Equivalent	3M COMPANY
K811247	CATHETER MAINTENANCE KIT	Jun 12, 1981	Substantially Equivalent	CLINIPAD CORP.
K811242	DISPOSABLE STERILIZATION WRAP	May 21, 1981	Substantially Equivalent	AMSCO CO.
K810918	ROLL-A-SET	May 21, 1981	Substantially Equivalent	PRINCIPLE BUSINESS ENT.
K810646	OR/CS WRAP	Mar 20, 1981	Substantially Equivalent	AMERICAN THRESHOLD INDUSTRIES, INC.
K803306	ALOFT STERILIZATION WRAP	Feb 05, 1981	Substantially Equivalent	AMERICAN HOSPITAL SUPPLY CORP.
K803294	GUARDIAN STERILIZATION WRAP	Feb 02, 1981	Substantially Equivalent	KIMBERLY-CLARK CORP.
K802919	ISO-BAC INSTRUMENT WRAP	Feb 02, 1981	Substantially Equivalent	AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL
K803293	GUARDIAN PEEL POUCHES	Jan 28, 1981	Substantially Equivalent	KIMBERLY-CLARK CORP.
K802577	HYPERALIMENTATION SUBCLAVIIAN DRESS TRAY	Nov 12, 1980	Substantially Equivalent	ASSOCIATED MEDICAL PRODUCTS CO.
K802428	PROPPER SHARPGUARD & TRAYPAD STERIL. AID	Oct 23, 1980	Substantially Equivalent	PROPPER MFG. CO., INC.
K801333	AMPCO DRESSING CHANGE TRAYS	Aug 22, 1980	Substantially Equivalent	ASSOCIATED MEDICAL PRODUCTS CO.
K801331	AMPCO HYPERALIMENTATION SUBCLAVIAN TRAYS	Aug 20, 1980	Substantially Equivalent	ASSOCIATED MEDICAL PRODUCTS CO.
K801569	VAL-U-WRAP CSR WRAP	Jul 28, 1980	Substantially Equivalent	AMERICAN CONVERTORS DIV., AMERICAN PHARMASEAL
K801332	AMPCO SKIN SCRUB TRAYS	Jun 20, 1980	Substantially Equivalent	ASSOCIATED MEDICAL PRODUCTS CO.
K800123	DEXTEX II STERILIZATION WRAP	Feb 13, 1980	Substantially Equivalent	AHLSTROM DEXTER
K792369	HYPERALIMENTATION DRESSING TRAY	Dec 10, 1979	Substantially Equivalent	PHARMASEAL DIV., BAXTER HEALTHCARE CORP.
K791513	ADAMCO DUST COVER	Oct 11, 1979	Substantially Equivalent	CHASE MFG. CO.
K781981	DECONTAMINATION ITEMS BAG	Dec 07, 1978	Substantially Equivalent	MEDICARE INDUSTRIES, INC.
K781980	RESPIRATORY THERAPY GAS POUCH	Dec 07, 1978	Substantially Equivalent	MEDICARE INDUSTRIES, INC.
K781925	POUCHES, GAS STERILIZATION	Nov 22, 1978	Substantially Equivalent	MEDICARE INDUSTRIES, INC.
K781924	POUCHES AND TUBING, MEDI-SEAL	Nov 22, 1978	Substantially Equivalent	MEDICARE INDUSTRIES, INC.
K781301	WRAP, STERILIZATION	Aug 10, 1978	Substantially Equivalent	STANFORD PROFESSIONAL PRODUCTS
K780294	G WRAP	Mar 28, 1978	Substantially Equivalent	CEL-FIBE
K780034	AUTOCLAVE POUCHES&ROLLS/STEAM&GAS	Feb 21, 1978	Substantially Equivalent	E.M. ADAMS
K771846	SUOGIPEEL PACKAGING SYSTEM	Oct 13, 1977	Substantially Equivalent	SURGICOT, INC.
K770933	BIO-SHIELD CSR WRAP	Sep 02, 1977	Substantially Equivalent	CONVERTORS
K771348	ECONOWRAP PAPER C.S.R. WRAP	Aug 02, 1977	Substantially Equivalent	TOWER PRODUCTS, INC.
K771032	POUCHES, PEEL OPEN, BREATHABLE	Jul 14, 1977	Substantially Equivalent	SURGICOT, INC.
K770797	TRAY, CATHETERIZATION W/FOLEY, STERILE	Jul 11, 1977	Substantially Equivalent	LUKENS CORP.
K770409	STERI-STOR TM	Apr 15, 1977	Substantially Equivalent	RESEARCH SURGICAL SYSTEMS
K770514	STERILIZER WRAP	Apr 07, 1977	Substantially Equivalent	C.R. BARD, INC.
K760662	STERIL.WRAP(#221901,2,3,4,5,6,7,8,9)	Dec 30, 1976	Substantially Equivalent	C.R. BARD, INC.
K760758	STERILIZATION PACKAGING MATERIALS	Dec 02, 1976	Substantially Equivalent	PAPER MANUFACTURERS CO.
K760661	STERILIZER WRAP (CAT#221831,2,3,4,5,6)	Dec 02, 1976	Substantially Equivalent	C.R. BARD, INC.

FEI Numbers

This FDA classification entry is associated with 203 FEI numbers. Click on an entry to view related FDA registrations.

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1000111202: 18 registrations

1000112877: 433 registrations

1000112968: 424 registrations

1000123222: 187 registrations

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1000137528: 104 registrations

1000160387: 6 registrations

1000160458: 173 registrations

1000162577: 2 registrations

1000199482: 1 registration

1000517638: 102 registrations

1000526834: 16 registrations

1017294: 217 registrations

1032227: 93 registrations

1032347: 186 registrations

1043214: 577 registrations

1043644: 30 registrations

1051614: 38 registrations

1053306: 2 registrations

1217231: 4 registrations

1220246: 388 registrations

1221053: 45 registrations

1319130: 61 registrations

1417592: 699 registrations

1526531: 18 registrations

1527185: 18 registrations

1527607: 18 registrations

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2183287: 2 registrations

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3013557562: 654 registrations

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3014456066: 14 registrations

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3015045320: 39 registrations

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3015068387: 14 registrations

3015133840: 11 registrations

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3016073670: 10 registrations

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3017230778: 6 registrations

3017452444: 20 registrations

3017498782: 28 registrations

3017910185: 43 registrations

3017949824: 9 registrations

3018047916: 4 registrations

3018781093: 22 registrations

3019848304: 22 registrations

3021010394: 4 registrations

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3021742060: 5 registrations

3023174629: 9 registrations

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3026297922: 481 registrations

3026408938: 290 registrations

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3034393266: 4 registrations

3035642068: 117 registrations

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3194: 23 registrations

6499: 8 registrations