Product Code: FTL FDA class 2 21 CFR 878.3300

Mesh, Surgical, Polymeric

General, Plastic Surgery

A polymeric surgical mesh is a synthetic, porous material implanted surgically to reinforce or reconstruct weakened or damaged tissue, commonly used in hernia repair and other reconstructive procedures. 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 FTL, regulated under 21 CFR 878.3300, within the General, Plastic Surgery medical specialty. This device is designated as an implant.

View on FDA

510(k)s

336

FEI Numbers

139

Registration Numbers

139

Unique Applicants

121

Years Active

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Basic Information

Product Code: FTL
Device Class: FDA class 2
Regulation Number: 878.3300
Medical Specialty: General, Plastic Surgery
Review Panel: SU
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 336 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253956	ProGrip advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)	May 21, 2026	Substantially Equivalent	Sofradim Production
K253125	Parietene Flat Sheet Mesh	Oct 24, 2025	Substantially Equivalent	Medtronic - Sofradim Production
K251955	Onflex Mesh	Jul 24, 2025	Substantially Equivalent	Davol Inc., Subsidiary of C. R. Bard, Inc.
K251557	Bard® Mesh; Bard® Mesh Pre-Shaped	Jun 12, 2025	Substantially Equivalent	Davol, Inc.
K250869	Parietene Macroporous Mesh (PPM5050 )	Apr 23, 2025	Substantially Equivalent	Sofradim Production
K250098	Bard Soft Mesh; Bard Soft Mesh Pre-Shaped	Apr 09, 2025	Substantially Equivalent	Davol, Inc.
K243315	ProGrip Self-Gripping Polypropylene Mesh	Jan 17, 2025	Substantially Equivalent	Sofradim Production
K241250	3DMax Light Mesh	Jun 14, 2024	Substantially Equivalent	Davol Inc., Subsidiary of C. R. Bard, Inc.
K232373	Progrip Self-Gripping Polypropylene Mesh	Jan 18, 2024	Substantially Equivalent	Sofradim Production
K233402	Bard 3DMax Mesh	Nov 01, 2023	Substantially Equivalent	Davol Inc., Subsidiary of C. R. Bard, Inc.
K232924	T-Line® Hernia Mesh	Oct 18, 2023	Substantially Equivalent	Deep Blue Medical Advances, Inc.
K230671	Pitch PaSoft Tissue Reinforcement Device	May 31, 2023	Substantially Equivalent	Xiros, Ltd.
K230227	T-Line Hernia Mesh	Feb 23, 2023	Substantially Equivalent	Deep Blue Medical Advances, Inc.
K223218	Parietene Macroporous Mesh	Dec 02, 2022	Substantially Equivalent	Sofradim Production
K221556	T-Line Hernia Mesh	Nov 28, 2022	Substantially Equivalent	Deep Blue Medical Advances, Inc.
K220540	ProGrip Self-Gripping Polypropylene Mesh	Sep 22, 2022	Substantially Equivalent	Covidien
K220091	Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device	Aug 26, 2022	Substantially Equivalent	Xiros, Ltd.
K220586	Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh	Jun 22, 2022	Substantially Equivalent	Sofradim Production
K211132	ARISTE AB Mesh	Mar 18, 2022	Substantially Equivalent	Ariste Medical, LLC
K211563	Pitch-Patchs	Aug 13, 2021	Substantially Equivalent	Xiros, Ltd.
K200918	SurgiWrap FROST	Jan 07, 2021	Substantially Equivalent	Mast Biosurgery
K201143	VICRYL Mesh	Aug 06, 2020	Substantially Equivalent	ETHICON, Inc.
K200818	3DMax MID Anatomical Mesh	Jul 17, 2020	Substantially Equivalent	C.R. Bard, Inc.
K192636	TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)	Apr 08, 2020	Substantially Equivalent	Medtronic, Inc.
K193144	T-Line Hernia Mesh	Mar 30, 2020	Substantially Equivalent	Deep Blue Medical Advances, Inc.
K192389	TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)	Mar 27, 2020	Substantially Equivalent	Medtronic, Inc.
K192443	Dextile Anatomical Mesh	Dec 06, 2019	Substantially Equivalent	Sofradim Production
K191373	VICRYL Mesh	Oct 22, 2019	Substantially Equivalent	ETHICON, Inc.
K192112	FlexBand Plus	Sep 27, 2019	Substantially Equivalent	International Life Sciences
K191545	Exogenesis Hernia Mesh	Sep 26, 2019	Substantially Equivalent	Exogenesis Corporation
K182008	Phasix ST Mesh with Echo 2 Positioning System	Dec 14, 2018	Substantially Equivalent	C.R. Bard, Inc.
K181935	Endoform Reconstructive Template - Non Absorbable	Dec 04, 2018	Substantially Equivalent	Aroa Biosurgery , Ltd.
K182087	DynaMesh-POSTERIOR	Oct 31, 2018	Substantially Equivalent	Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft
K181094	Polydioxanone Surgical Scaffold	Aug 02, 2018	Substantially Equivalent	Lntegra Lifesciences
K181268	PROLENE (Polypropylene) 3D Patch	Jul 26, 2018	Substantially Equivalent	ETHICON, Inc.
K180910	ULTRAPRO Mesh and ULTRAPRO ADVANCED	Jul 02, 2018	Substantially Equivalent	ETHICON, Inc.
K180829	PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh	Jun 28, 2018	Substantially Equivalent	ETHICON, Inc.
K180122	TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)	Jun 07, 2018	Substantially Equivalent	Medtronic, Inc.
K172636	VitaMESH Macroporous PP Surgical Mesh	Apr 30, 2018	Substantially Equivalent	Proxy Biomedical , Ltd.
K180030	TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)	Apr 24, 2018	Substantially Equivalent	Medtronic, Inc.
K173796	Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)	Mar 09, 2018	Substantially Equivalent	Sofradim Production
K172395	Duatene bilayer mesh	Feb 01, 2018	Substantially Equivalent	Sofradim Production
K172089	PROLENE Soft Polypropylene Mesh	Oct 05, 2017	Substantially Equivalent	ETHICON, Inc.
K170134	Reperen Surgical Mesh	Aug 09, 2017	Substantially Equivalent	Iconlab, Inc.
K163212	Parietene DS Composite Mesh	Jun 29, 2017	Substantially Equivalent	Sofradim Production
K163576	GORE SYNECOR Preperitoneal Biomaterial	May 11, 2017	Substantially Equivalent	W. L. Gore & Associates, Inc.
K170294	VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4x 6) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6x8) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6x10) Oval	May 01, 2017	Substantially Equivalent	C. R. Bard
K163152	PROLENE Soft Polypropylene Mesh	Mar 11, 2017	Substantially Equivalent	ETHICON, Inc.
K161550	DynaMesh-VENTRAL	Dec 22, 2016	Substantially Equivalent	Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft
K153632	Endoform Reconstructive Template	Jun 16, 2016	Substantially Equivalent	Aroa Biosurgery Limited (Formerly Mesynthes Limited)
K153236	Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay	May 13, 2016	Substantially Equivalent	C.R. Bard, Inc.
K152609	GORE SYNECOR Biomaterial	Dec 11, 2015	Substantially Equivalent	W. L. Gore & Associates, Inc.
K152678	TYRX Neuro Antibacterial Envelope	Nov 17, 2015	Substantially Equivalent	Tyrx, Inc.
K151386	C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic	Oct 22, 2015	Substantially Equivalent	Atrium Medical Corporation
K143743	ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH	Sep 18, 2015	Substantially Equivalent	C.R. Bard, Inc.
K151437	ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug	Aug 27, 2015	Substantially Equivalent	Atrium Medical Corporation
K150906	ULTRAPRO ADVANCED Macroporous Partically Absorbable Mesh	Jul 24, 2015	Substantially Equivalent	Ehicon, Inc.
K150091	Versatex Monofilament Mesh	May 26, 2015	Substantially Equivalent	Sofradim Production
K142192	Insightra Freedom Ventral Hernia Repair System	May 07, 2015	Substantially Equivalent	Insightra Medical
K150291	TYRX Neuro Absorbable Antibacterial Envelope	Mar 27, 2015	Substantially Equivalent	Medtronic Tyrx, Inc.
K142706	Modified ONFLEX Mesh	Mar 25, 2015	Substantially Equivalent	C.R. Bard, Inc.
K142711	ONFLEX Mesh	Mar 20, 2015	Substantially Equivalent	C.R. Bard, Inc.
K143386	Progrip Laparoscopic Self-Fixating Mesh	Mar 13, 2015	Substantially Equivalent	Sofradim Production
K142611	TYRX Neuro Absorbable Antibacterial Envelope	Dec 31, 2014	Substantially Equivalent	Medtronic Tyrx, Inc.
K142908	Parietex Monofilament Polyester Mesh (new name: Parietex Lightweight Mesh), Parietex Composite Mono PM Mesh (new name: Parietex Composite Parastomal Mesh), Parietex Composite Ventral Patch, Symbotex Composite Mesh	Nov 14, 2014	Substantially Equivalent	Sofradim Production
K142900	Parietex Progrip Mesh (new name: Progrip Self-Gripping Polyester Mesh), Parietex Plug and Patch (new name : Parietex Plug and Patch System), Progrip Laparoscopic Self-Fixating Mesh	Oct 28, 2014	Substantially Equivalent	Sofradim Production
K141560	ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE	Oct 23, 2014	Substantially Equivalent	ETHICON, Inc.
K142091	PARIETENE MACROPOROUS MESH	Oct 17, 2014	Substantially Equivalent	Sofradim Production
K133889	PREMIUM	Sep 04, 2014	Substantially Equivalent	Cousin Biotech Sas
K141394	X-REPAIR	Aug 06, 2014	Substantially Equivalent	Synthasome
K141499	X-REPAIRSL	Jul 02, 2014	Substantially Equivalent	Synthasome, Inc.
K140967	FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK	Jun 10, 2014	Substantially Equivalent	Insightra Medical
K133198	ULTRAPRO COMFORT PLUG	May 30, 2014	Substantially Equivalent	ETHICON, Inc.
K140941	PROGRIP SELF-GRIPPING POLYPROPYLENE MESH, PARIETENE FLAT SHEET MESH	May 07, 2014	Substantially Equivalent	Sofradim Production
K132441	BARD VENTRALEX HERNIA PATCH	Dec 13, 2013	Substantially Equivalent	C.R. Bard, Inc.
K132699	AIGIS RX N (MEDIUM), AIGIS RX N (LARGE)	Nov 26, 2013	Substantially Equivalent	Tyrx, Inc.
K130428	COVAMESH	Oct 25, 2013	Substantially Equivalent	Biomup S.A.
K131530	DYNAMESH -CICAT	Oct 23, 2013	Substantially Equivalent	Feg Textiltechnik Forschungs-Und Entwicklungsgesel
K131969	SYMBOTEX(TM) COMPOSITE MESH	Aug 22, 2013	Substantially Equivalent	Sofradim Production
K131007	AIGIS RX N MEDIUM; AIGIS RX N LARGE	Jul 10, 2013	Substantially Equivalent	Tyrx, Inc.
K130943	AIGIS RX R PM/ AIGIS RX R ICD	May 20, 2013	Substantially Equivalent	Tyrx, Inc.
K130968	VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM	May 01, 2013	Substantially Equivalent	C.R. Bard, Inc.
K120844	MEDLINX SURGICAL MESH	Dec 13, 2012	Substantially Equivalent	Medlinx Acala Pte, Ltd.
K123479	PROGRIP LAPAROSCOPIC SELF-FIXATING MESH	Dec 11, 2012	Substantially Equivalent	Sofradim Production
K122436	COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM	Nov 02, 2012	Substantially Equivalent	C.R. Bard, Inc.
K113552	FREEDOM INGUINAL HERNIA IMPLANT	Aug 23, 2012	Substantially Equivalent	Insightra Medical
K113229	VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING	Jul 20, 2012	Substantially Equivalent	C.R. Bard, Inc.
K113311	TIO2MESH TM	Jul 17, 2012	Substantially Equivalent	Biocer Entwicklungs GmbH
K120897	PROGRIP LAPARSCOPIC SELF-FIXATING MESH	Jun 29, 2012	Substantially Equivalent	Sofradim Production
K120025	SURGIMESH XB - SKIRTED	Jun 26, 2012	Substantially Equivalent	Aspide Medical
K120506	PARIETEX COMPOSITE VENTRAL PATCH	Jun 13, 2012	Substantially Equivalent	Sofradim Production
K121070	C-QUR RPM MESH	Apr 26, 2012	Substantially Equivalent	Atrium Medical Corp.
K111695	HYBRID GRAFT	Apr 02, 2012	Substantially Equivalent	Cook Biotech, Inc.
K111337	TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD	Jan 25, 2012	Substantially Equivalent	Tornier, Inc.
K112567	BIOMERIX ASSURE	Dec 23, 2011	Substantially Equivalent	Biomerix Corporation
K112499	BIOMERIX COMPOSITE SURGICAL MESH	Dec 23, 2011	Substantially Equivalent	Biomerix Corporation
K112784	RENASYS AB ABOMINAL DRESSING KIT	Nov 22, 2011	Substantially Equivalent	Smith & Nephew, Inc.
K110663	PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)	Aug 11, 2011	Substantially Equivalent	Sofradim Production
K100313	HYDROFIX SURGICAL SHEET	Jun 14, 2011	Substantially Equivalent	Mimedx Group, Inc.
K111121	VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH	May 13, 2011	Substantially Equivalent	Proxy Biomedical , Ltd.
K102788	TORNIER BIOFIBER SCAFFOLD	May 10, 2011	Substantially Equivalent	Tornier, Inc.
K110816	PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)	Apr 19, 2011	Substantially Equivalent	Sofradim Production
K110815	PARIETEX OPTIMIZED COMPOSTIE MESH	Apr 19, 2011	Substantially Equivalent	Sofradim Production
K110820	VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM	Apr 01, 2011	Substantially Equivalent	C.R. Bard, Inc.
K101928	VENTRALEX ST HERNIA PATCH	Mar 23, 2011	Substantially Equivalent	C.R. Bard, Inc.
K101920	VENTRIO ST HERNIA PATCH	Mar 23, 2011	Substantially Equivalent	C.R. Bard, Inc.
K103682	PARIETEX PROGRIP	Mar 04, 2011	Substantially Equivalent	Sofradim Production
K103445	ALACER SURGICAL SCAFFOLD	Feb 22, 2011	Substantially Equivalent	Alacer Biomedical, Inc.
K110110	ATRIUM CENTRILFX MESH	Feb 15, 2011	Substantially Equivalent	Atrium Medical Corporation
K103568	RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH	Dec 22, 2010	Substantially Equivalent	Coloplast A/S
K102766	COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM	Dec 16, 2010	Substantially Equivalent	C.R. Bard, Inc.
K101519	PARIETEX PLUG AND PATCH	Nov 05, 2010	Substantially Equivalent	Sofradim Production
K100787	RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT	Sep 17, 2010	Substantially Equivalent	Smith & Nephew, Inc.
K101462	ASCEND BLUE AC MESH; ASCEND BLUE PC MESH	Aug 16, 2010	Substantially Equivalent	Caldera Medical, Inc.
K101851	VENTRALIGHT ST MESH	Jul 15, 2010	Substantially Equivalent	Davol Inc., Sub. C. R. Bard, Inc.
K093196	BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09	Jun 25, 2010	Substantially Equivalent	Cousin Biotech Sas
K092233	SURGIMESH XD	Jun 25, 2010	Substantially Equivalent	Aspide Medical
K093123	BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB	May 13, 2010	Substantially Equivalent	Biomerix Corporation
K101197	PARIE TENE PROGRIP MESH	May 05, 2010	Substantially Equivalent	Sofradim Production
K093799	TORNIER SURGICAL MESH	Apr 22, 2010	Substantially Equivalent	Tornier, Inc.
K100229	VENTRIO HERNIA PATCH	Apr 21, 2010	Substantially Equivalent	C.R. Bard, Inc.
K093932	ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH	Apr 09, 2010	Substantially Equivalent	Ethicon GmbH
K093524	PIVIT A/B ST AND PIVIT A/B ST-R	Mar 26, 2010	Substantially Equivalent	Tyrx, Inc.
K092538	REFINE SUPPORT SYSTEM, MODEL 100.0100	Mar 05, 2010	Substantially Equivalent	Alure Medical, Inc.
K100076	ATRIUM C-QUR OVT MESH	Jan 26, 2010	Substantially Equivalent	Atrium Medical Corp.
K092224	TIGR SURGICAL MESH , MODEL WK-6	Jan 25, 2010	Substantially Equivalent	Novus Scientific Pte, Ltd.
K090271	HYDROCOAT MESH	Jan 14, 2010	Substantially Equivalent	Promethean Surgical Devices, Inc.
K092032	BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160	Dec 08, 2009	Substantially Equivalent	Davol Inc., Sub. C. R. Bard, Inc.
K093166	WITTMANN PATCH	Dec 07, 2009	Substantially Equivalent	Aperta, LLC
K091659	BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732	Aug 03, 2009	Substantially Equivalent	C.R. Bard, Inc.
K090909	C-QUR V -PATCH MESH	Jun 04, 2009	Substantially Equivalent	Atrium Medical Corp.
K090934	PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM	Jun 02, 2009	Substantially Equivalent	American Medical Systems, Inc.
K090489	ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026	May 14, 2009	Substantially Equivalent	Kci USA, Inc.
K083102	REFINE LIFT SYSTEM	May 11, 2009	Substantially Equivalent	Alure Medical, Inc.
K090858	PARIETEX MONOFILAMENT POLYESTER MESH	May 06, 2009	Substantially Equivalent	Sofradim Production
K090288	ORTHADAPT PR	May 05, 2009	Substantially Equivalent	Pegasus Biologics, Inc.
K083467	REBOUND HRDV	Apr 23, 2009	Substantially Equivalent	Minnesota Medical Development, Inc.
K083307	SYNTHASOME X-REPAIR	Mar 27, 2009	Substantially Equivalent	Synthasome, Inc.
K083266	GORE BIO-A FISTULA PLUG	Mar 27, 2009	Substantially Equivalent	W. L. Gore & Associates, Inc.
K081377	NUVASIVE SURGICAL MESH SYSTEM	Jan 15, 2009	Substantially Equivalent	Nuvasive, Inc.
K082748	ATRIUM PROLITE S MESH	Jan 14, 2009	Substantially Equivalent	Atrium Medical Corp.
K082941	BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215	Jan 07, 2009	Substantially Equivalent	Biomerix Corporation
K080442	SERISCAFFOLD SURGICAL MESH	Nov 13, 2008	Substantially Equivalent	Serica Technologies, Inc.
K081010	BARD 3DMAX MESH	Oct 07, 2008	Substantially Equivalent	Davol Inc., Sub. C. R. Bard, Inc.
K081777	VENTRIO HERNIA PATCH	Sep 29, 2008	Substantially Equivalent	C.R. Bard, Inc.
K080216	SUPRAMESH EXTRA	Sep 15, 2008	Substantially Equivalent	S. Jackson, Inc.
K082216	TBD ETHICON MESH	Sep 05, 2008	Substantially Equivalent	ETHICON, Inc.
K073579	DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN	Aug 18, 2008	Substantially Equivalent	Feg Textiltechnik Forschungs-Und Entwicklungsgesel
K072974	SURGIMESH XB	Aug 18, 2008	Substantially Equivalent	Aspide Medical
K081126	PARIETEX COMPOSITE MONO PM MESH	Aug 13, 2008	Substantially Equivalent	Sofradim Production
K072370	SURGICRAFT SURGICAL MESH SYSTEM	Jul 24, 2008	Substantially Equivalent	Surgicraft , Ltd.
K072962	CABS'AIR	Jun 26, 2008	Substantially Equivalent	Cousin Biotech Sas
K081327	RELIMESH	Jun 19, 2008	Substantially Equivalent	Herniamesh S.R.L.
K081069	GORE INFINIT MESH	May 30, 2008	Substantially Equivalent	W. L. Gore & Associates, Inc.
K081050	PARIETEX PROGRIP MESH	May 28, 2008	Substantially Equivalent	Sofradim Production
K080836	MODIFICATION TO ENDOFAST RELIANT SYSTEM	Apr 21, 2008	Substantially Equivalent	Endogun Medical Systems
K080691	C-QUR EDGE MESH V-PATCH	Apr 16, 2008	Substantially Equivalent	Atrium Medical Corp.
K080688	C-QUR LITE MESH V-PATCH	Apr 16, 2008	Substantially Equivalent	Atrium Medical Corp.
K080353	LTM-T SURGICAL MESH	Apr 03, 2008	Substantially Equivalent	Lifecell Corp.
K080393	MODIFICATION TO REBOUND HRD	Mar 13, 2008	Substantially Equivalent	Minnesota Medical Development, Inc.
K073287	PREVADH MESH	Mar 13, 2008	Substantially Equivalent	Sofradim Production
K073164	IVS TUNNELLER DEVICES	Mar 05, 2008	Substantially Equivalent	Covidien UK Manufacturing, Ltd.
K070961	BIOMERIX SURGICAL MESH, MODEL: RCR-01	Feb 25, 2008	Substantially Equivalent	Biomerix Corporation
K072190	ORTHO-WRAP BIORESORBABLE SHEET	Jan 16, 2008	Substantially Equivalent	Mast Biosurgery
K063091	PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601	Jan 16, 2008	Substantially Equivalent	Tyrx Pharma, Inc.
K071695	KENSEY NASH MACROPORE SHIELD	Dec 31, 2007	Substantially Equivalent	Kensey Nash Corp.
K072520	TEPHAFLEX SURGICAL FILM	Nov 29, 2007	Substantially Equivalent	Tepha, Inc.
K071887	SPORTMESH OR ARTELON TISSUE REINFORCEMENT	Sep 18, 2007	Substantially Equivalent	Artimplant AB
K071470	IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX	Aug 31, 2007	Substantially Equivalent	Implantech Associates, Inc.
K070918	4DDOME	Aug 22, 2007	Substantially Equivalent	Cousin Biotech
K063671	REBOUND HRD	Aug 16, 2007	Substantially Equivalent	Minnesota Medical Development, Inc.
K070625	PELVIMESH / HERMESH 7	Aug 01, 2007	Substantially Equivalent	Marketing Solutions, Inc.
K061934	XTAC	Jul 17, 2007	Substantially Equivalent	Osteogenics, Inc.
K071629	PARIETEX POLYESTER MESH WITH INTRODUCER	Jul 10, 2007	Substantially Equivalent	Sofradim Production
K063154	FACIAL RECONSTRUCTIVE MESH (FRM)	Jul 10, 2007	Substantially Equivalent	Evera Medical, Inc.
K070846	MINISLING ADJUSTABLE POLYMER SLING & SURGICAL MESH WITH SELF-ANCHORING SYSTEM	Jul 02, 2007	Substantially Equivalent	Prosurg, Inc.
K071249	ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV	Jun 05, 2007	Substantially Equivalent	ETHICON, Inc.
K070993	TOPAS SYSTEM	May 09, 2007	Substantially Equivalent	American Medical Systems, Inc.
K070018	UNIVERSAL SURGICAL MESH, MODEL 100	Apr 27, 2007	Substantially Equivalent	Generic Medical Device, Inc.
K070224	ULTRAPRO PLUG	Apr 17, 2007	Substantially Equivalent	ETHICON, Inc.
K070644	GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS	Apr 02, 2007	Substantially Equivalent	W. L. Gore & Associates, Inc.
K070192	ATRIUM PROLITE ULTRA S MESH	Mar 08, 2007	Substantially Equivalent	Atrium Medical Corp.
K063648	SURGI-WRAP MAST TENDON SHEET	Mar 07, 2007	Substantially Equivalent	Mast Biosurgery USA, Inc.
K061445	SURGIMESH WN	Feb 01, 2007	Substantially Equivalent	Aspide Medical
K063739	SEPRAMESH, MODEL 5959-1214	Jan 17, 2007	Substantially Equivalent	Genzyme Corporation
K061533	PROCEED VENTRAL PATCH	Dec 11, 2006	Substantially Equivalent	ETHICON, Inc.
K063435	GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL	Nov 28, 2006	Substantially Equivalent	W. L. Gore & Associates, Inc.
K061754	BARD COMPOSITE L/P MESH	Oct 23, 2006	Substantially Equivalent	Davol Inc., Sub. C. R. Bard, Inc.
K062697	SIS HERNIA REPAIR DEVICE, SURGISIS GOLD HERNIA REPAIR GRAFT	Oct 13, 2006	Substantially Equivalent	Cook Biotech, Inc.
K061473	SURGI-WRAP MAST BIORESORBABLE SHEET	Sep 21, 2006	Substantially Equivalent	Mast Biosurgery USA, Inc.
K060329	ENDOFAST RELIANT SYSTEM	Sep 11, 2006	Substantially Equivalent	Endogun Medical Systems
K060018	TRULENE MESH	Jul 26, 2006	Substantially Equivalent	Sutures India Pvt., Ltd.
K061704	OPTILENE MESH	Jul 19, 2006	Substantially Equivalent	Aesculap, Inc.
K053215	SURGICAL MESH SYSTEM	Jul 17, 2006	Substantially Equivalent	Nuvasive, Inc.
K053656	TYRX ANTIMICROBIAL MESH	Jul 14, 2006	Substantially Equivalent	Tyrx Pharma, Inc.
K061314	BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH	Jun 02, 2006	Substantially Equivalent	Davol Inc., Sub. C. R. Bard, Inc.
K060713	PROCEED SURGICAL MESH	May 25, 2006	Substantially Equivalent	ETHICON, Inc.
K050311	ATRIUM MEDICAL CORPORATION C-QUR MESH	Mar 31, 2006	Substantially Equivalent	Atrium Medical Corp.
K060520	VITAMESH MACROPOROUS PP SURGICAL MESH	Mar 28, 2006	Substantially Equivalent	Proxy Biomedical , Ltd.
K060004	CALDERA MESH	Feb 22, 2006	Substantially Equivalent	Caldera Medical, Inc.
K053424	POPMESH	Feb 22, 2006	Substantially Equivalent	Caldera Medical, Inc.
K052830	SPORTMESH	Jan 19, 2006	Substantially Equivalent	Artimplant AB
K053158	OPTILENE MESH LP	Jan 18, 2006	Substantially Equivalent	Aesculap, Inc.
K052864	TYRX SURGICAL MESH, MODEL SMPC-0501	Dec 22, 2005	Substantially Equivalent	Tyrx Pharma, Inc.
K053066	SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH	Dec 19, 2005	Substantially Equivalent	Genzyme Corporation
K053202	GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL	Dec 07, 2005	Substantially Equivalent	W.L. Gore & Associates
K053200	GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL	Dec 07, 2005	Substantially Equivalent	W. L. Gore & Associates, Inc.
K052155	BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED	Oct 20, 2005	Substantially Equivalent	C.R. Bard, Inc.
K051701	VICRYL * MESH BAG	Sep 29, 2005	Substantially Equivalent	ETHICON, Inc.
K050969	INCLOSE SURGICAL MESH SYSTEM	Aug 18, 2005	Substantially Equivalent	Anulex Technologies, Inc.
K052100	MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH	Aug 11, 2005	Substantially Equivalent	Proxy Biomedical , Ltd.
K051766	ORTHOMEND	Aug 11, 2005	Substantially Equivalent	Tei Biosciences, Inc.
K050332	SURGI-WRAP MAST BIORESORBABLE SHEET	May 27, 2005	Substantially Equivalent	Mast Biosurgery USA, Inc.
K050678	MOTIFMESH SOFT TISSUE PATCH	May 20, 2005	Substantially Equivalent	Proxy Biomedical , Ltd.
K050418	TISSUE FIXATION SYSTEM	May 16, 2005	Substantially Equivalent	Tfs Manufacturing Pty, Ltd.
K043191	REPOL ANGIMESH, ANGIMESH PRE, FOLDED MESH, REPOL PLUG BASIC, REPOL PLUG CAP, REPOL PLUG FLOWER AND WINGS MESH	May 16, 2005	Substantially Equivalent	Angiologica B. M. Srl
K050187	PARIETEX COMPOSITE PCO-OS AND PCO-OB MESHES	Feb 18, 2005	Substantially Equivalent	Sofradim Production
K043081	GORE POLYPROPYLENE HERNIA MESH	Dec 22, 2004	Substantially Equivalent	W. L. Gore & Associates, Inc.
K043056	GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL	Dec 22, 2004	Substantially Equivalent	W. L. Gore & Associates, Inc.
K043366	PERMACOL SURGICAL IMPLANT	Dec 17, 2004	Substantially Equivalent	Tissue Science Laboratories, Plc
K042811	VIVOSORB SHEET, MODEL FS01	Nov 08, 2004	Substantially Equivalent	Polyganics B.V.,
K042026	BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004	Sep 10, 2004	Substantially Equivalent	C.R. Bard, Inc.
K040998	MODIFICATION TO PARIETEX COMPOSITE (PCO) MESH	Apr 29, 2004	Substantially Equivalent	Sofradim Production
K033337	ULTRAPRO MESH	Apr 01, 2004	Substantially Equivalent	ETHICON, Inc.
K033814	BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007	Mar 01, 2004	Substantially Equivalent	C.R. Bard, Inc.
K033376	UGYTEX MESH	Jan 15, 2004	Substantially Equivalent	Sofradim Production
K032893	SHELHIGH NO-REACT BIOCUFF	Dec 19, 2003	Substantially Equivalent	Shelhigh, Inc.
K032865	GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL	Nov 28, 2003	Substantially Equivalent	W. L. Gore & Associates, Inc.
K032673	IMMIX PLASTIFILM	Oct 02, 2003	Substantially Equivalent	Osteobiologics, Inc.
K031225	TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004	Sep 29, 2003	Substantially Equivalent	Gfe Medizintechnik GmbH
K031955	MACROPORE SURGI-WRAP MAST BIORESORBABLE SHEET	Sep 22, 2003	Substantially Equivalent	Macropore Biosurgery, Inc.
K031925	PROCEED TRILAMINATE SURGICAL MESH	Sep 17, 2003	Substantially Equivalent	ETHICON, Inc.
K032168	GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL	Aug 15, 2003	Substantially Equivalent	W. L. Gore & Associates, Inc.
K031188	ORTHOMEND	Jun 27, 2003	Substantially Equivalent	Tei Biosciences, Inc.
K030631	ZIPPERE - BIOABSORBABLE/NON-ABSORBABLE POLYMER SLING & SURGICAL MESH	May 19, 2003	Substantially Equivalent	Prosurg, Inc.
K024199	IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP	Mar 14, 2003	Substantially Equivalent	Osteobiologics, Inc.
K022011	V.A.C. ABDOMINAL DRESSING	Feb 26, 2003	Substantially Equivalent	Kinetic Concepts, Inc.
K024008	SMALL BARD VENTRALEX PATCH	Feb 20, 2003	Substantially Equivalent	C.R. Bard, Inc.
K023328	REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH	Dec 12, 2002	Substantially Equivalent	Center For Biomaterials and Advanced Technologies
K021835	BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX	Oct 17, 2002	Substantially Equivalent	Brennen Medical, Inc.
K022782	DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL	Sep 10, 2002	Substantially Equivalent	W. L. Gore & Associates, Inc.
K022350	BARD CRURASOFT PATCH, MODELS 0116003 & 0116001	Aug 23, 2002	Substantially Equivalent	C.R. Bard, Inc.
K021736	BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301	Jul 16, 2002	Substantially Equivalent	C.R. Bard, Inc.
K014183	AFB (ABSORBABLE FOAM BUTTRESS)	Jun 12, 2002	Substantially Equivalent	J&J Corporate Biomaterials Center
K012025	MACROPORE SURGIWRAP (TS)	Dec 03, 2001	Substantially Equivalent	Macropore Biosurgery, Inc.
K010533	BIOSLING - BIOABSORBABLE POLYMER SLING & SURGICAL MESH	May 24, 2001	Substantially Equivalent	Injectx, Inc.
K010722	PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH	Apr 27, 2001	Substantially Equivalent	ETHICON, Inc.
K010035	IVS TUNNELLER	Apr 04, 2001	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K010228	GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES	Feb 21, 2001	Substantially Equivalent	W. L. Gore & Associates, Inc.
K002699	PARIETEX COMPOSITE (PCO) MESH	Feb 15, 2001	Substantially Equivalent	Medical Device Consultants, Inc.
K003917	MODIFICATION TO FLUOROTEX II SURGICAL MESH	Jan 26, 2001	Substantially Equivalent	Bridger Biomed, Inc.
K003906	MODIFICATION TO FLUROTEX SURGICAL MESH	Jan 26, 2001	Substantially Equivalent	Bridger Biomed, Inc.
K003990	SOFRADIM PARIETEX SURGICAL MESHES	Jan 24, 2001	Substantially Equivalent	Sofradim Production
K003323	COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205	Jan 22, 2001	Substantially Equivalent	Davol, Inc.
K002721	AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH	Nov 29, 2000	Substantially Equivalent	American Medical Systems, Inc.
K002672	VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH	Nov 22, 2000	Substantially Equivalent	ETHICON, Inc.
K002479	BIOMESH P1 AND BIOMESH PLUG AND PATCH	Oct 19, 2000	Substantially Equivalent	Cousin Biotech S.A.R.L
K002684	COMPOSIX E/X MESH	Oct 11, 2000	Substantially Equivalent	C.R. Bard, Inc.
K002351	FLUOROTEX II SURGICAL MESH	Aug 26, 2000	Substantially Equivalent	Bridger Biomed, Inc.
K002093	ATRIUM LITE MESH	Jul 24, 2000	Substantially Equivalent	Atrium Medical Corp.
K002071	SOFTFORM SOFT TISSUE AUGMENTATION TUBE WITH INSERTION TOOL MODIFICATIONS FOR STRANDS AND SUTURE HOLES	Jul 24, 2000	Substantially Equivalent	Tissue Technologies, Inc.
K001122	PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH	May 23, 2000	Substantially Equivalent	ETHICON, Inc.
K000849	SOFTFORM FACIAL IMPLANT	May 19, 2000	Substantially Equivalent	Tissue Technologies, Inc.
K994328	SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX	Mar 02, 2000	Substantially Equivalent	Genzyme Corp.
K992556	PERMACOL	Feb 17, 2000	Substantially Equivalent	Tissue Science Laboratories, Plc
K000185	GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM)	Feb 14, 2000	Substantially Equivalent	W. L. Gore & Associates, Inc.
K992991	ATRIUM MEDICAL CORPORATION ADVANTA PTFE FACIAL IMPLANT	Jan 27, 2000	Substantially Equivalent	Atrium Medical Corp.
K983753	STAR TEMPORARY WOUND COVER	Nov 18, 1999	Substantially Equivalent	Osteogenics, Inc.
K992189	GORE-TEX DUALMESH BIOMATERIAL	Jul 29, 1999	Substantially Equivalent	W. L. Gore & Associates, Inc.
K991400	PARIETENE POLYPROPYLENE MESH	Jul 12, 1999	Substantially Equivalent	Sofradim Production
K991637	BARD SPERMA-TEX PRESHAPED MESH (2.4X5.6), MODEL 0114700	Jun 22, 1999	Substantially Equivalent	Davol Inc., Sub. C. R. Bard, Inc.
K990930	3D ANATOMICAL MESH	Jun 17, 1999	Substantially Equivalent	Santerra Medical Technology, Inc.
K984220	MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH	Feb 23, 1999	Substantially Equivalent	ETHICON, Inc.
K982532	PARIETEX	Jan 20, 1999	Substantially Equivalent	Cogent
K984197	FLUOROTEX SURGICAL MESH	Jan 07, 1999	Substantially Equivalent	Bridger Biomed, Inc.
K982575	MESH, SURGICAL, POLYMERIC	Nov 06, 1998	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K982475	SOFT TISSUE AUGMENTATION YUBE WITH INSERTION TOOL	Sep 22, 1998	Substantially Equivalent	Tissue Technologies, Inc.
K981756	SHELHIGH NO-REACT PNEUMOPLEDGETS	Aug 05, 1998	Substantially Equivalent	Shelhigh, Inc.
K974540	SIS HERNIA REPAIR DEVICE	May 20, 1998	Substantially Equivalent	Sentron Medical, Inc.
K973955	HERNIAMESH SURGICAL MESHES	May 11, 1998	Substantially Equivalent	Herniamesh
K980483	MENTOR SUSPEND SLING	Apr 30, 1998	Substantially Equivalent	Mentor Corp.
K981051	SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES	Apr 15, 1998	Substantially Equivalent	W. L. Gore & Associates, Inc.
K973462	SOFTFORM FACIAL IMPLANT	Nov 24, 1997	Substantially Equivalent	Tissue Technologies, Inc.
K973082	VENTRAL WALL DEFECT REDUCTION SILO	Nov 04, 1997	Substantially Equivalent	Specialty Surgical Products, Inc.
K972412	PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH	Sep 10, 1997	Substantially Equivalent	ETHICON, Inc.
K971745	BARD COMPOSITE PROSTHESIS	Aug 06, 1997	Substantially Equivalent	Davol Inc., Sub. C. R. Bard, Inc.
K970561	GRAFT PATCH	Aug 01, 1997	Substantially Equivalent	Organogenesis, Inc.
K971472	SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING, REINFORCED RADIOPAQUE SHEETING, EXTRA FIRM GRA	Jul 01, 1997	Substantially Equivalent	Technical Products, Inc.
K964857	RAPISEAL PATCH	Feb 18, 1997	Substantially Equivalent	Fusion Medical Technologies, Inc.
K965038	GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE	Feb 06, 1997	Substantially Equivalent	W. L. Gore & Associates, Inc.
K964761	S.A.M. FACIAL IMPLANT W/INTRODUCER	Jan 27, 1997	Substantially Equivalent	W. L. Gore & Associates, Inc.
K963226	SURGICAL FABRICS	Nov 15, 1996	Substantially Equivalent	Boston Scientific Corp
K963619	GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES	Oct 25, 1996	Substantially Equivalent	W. L. Gore & Associates, Inc.
K963141	KUGEL HERNIA PATCH	Oct 11, 1996	Substantially Equivalent	Douglas Bueschel
K962971	POLYPROPYLENE MESH (VARIOUS SIZES)	Sep 16, 1996	Substantially Equivalent	Davis & Geck, Inc.
K962496	SOFT TISSUE AUGMENTATION TUBE (S.T.A.T.)	Sep 03, 1996	Substantially Equivalent	Tissue Technologies, Inc.
K962401	GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES	Sep 03, 1996	Substantially Equivalent	W. L. Gore & Associates, Inc.
K962530	PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH	Aug 09, 1996	Substantially Equivalent	ETHICON, Inc.
K961440	SURGICAL PATCH, SURGICAL MEMBRANE, SURGICAL MESH	May 31, 1996	Substantially Equivalent	Fusion Medical Technologies, Inc.
K960481	SOFT TISSUE AUGMENTATION TUBE	Apr 01, 1996	Substantially Equivalent	Tissue Technologies, Inc.
K960219	PROLEX MESH	Mar 15, 1996	Substantially Equivalent	Advanced Surgical Innovations, Inc.
K954665	GLYCAR STAPLE STRIPS	Feb 14, 1996	Substantially Equivalent	Glycar, Inc.
K955494	GORE-TEX DUALMESH BIOMATERIAL WITH HOLES	Jan 24, 1996	Substantially Equivalent	W. L. Gore & Associates, Inc.
K952898	GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER	Nov 14, 1995	Substantially Equivalent	W. L. Gore & Associates, Inc.
K951700	GORE-TEX SOFT TISSUE PATCH	Oct 07, 1995	Substantially Equivalent	W. L. Gore & Associates, Inc.
K951676	GORE-TEX DUALMESH BIOMATERIAL	Oct 07, 1995	Substantially Equivalent	W. L. Gore & Associates, Inc.
K951675	GORE-TEX MYCROMESH BIOMATERIAL	Oct 07, 1995	Substantially Equivalent	W. L. Gore & Associates, Inc.
K953577	BARD VISILEX MESH 3 X 6	Sep 26, 1995	Substantially Equivalent	Davol Inc., Sub. C. R. Bard, Inc.
K946107	GORE-TEX MYCROMESH PLUS BIOMATERIAL	Apr 24, 1995	Substantially Equivalent	W. L. Gore & Associates, Inc.
K946106	GORE-TEX DUALMESH PLUS BIOMATERIAL	Apr 24, 1995	Substantially Equivalent	W. L. Gore & Associates, Inc.
K945060	HERNIA MESH INTRODUCTION SYSTEM	Mar 02, 1995	Substantially Equivalent	Gerard Medical, Inc.
K945899	GORE-TEX(R) CURVED SURGICALMEMBRANE	Feb 13, 1995	Substantially Equivalent	W. L. Gore & Associates, Inc.
K942911	GLYCAR TISSUE REPAIR PATCH	Dec 14, 1994	Substantially Equivalent	Glycar, Inc.
K945377	TRELEX NATURAL(R) MESH	Dec 08, 1994	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K944413	ACM PTFE SURGICAL MESH	Nov 09, 1994	Substantially Equivalent	American Custom Medical, Inc.
K922452	GORE-TEX SOFT TISSUE PATCH PLUS	Sep 29, 1994	Substantially Equivalent	W. L. Gore & Associates, Inc.
K941299	FLARED PATCH	Aug 23, 1994	Substantially Equivalent	Flared Patch, Inc.
K942583	PERI-STRIPS PLANAR CONFIGURATION STAPLE LINE REINFORCEMENT	Jul 08, 1994	Substantially Equivalent	Bio-Vascular, Inc.
K933827	BIOSIL MEDICAL GRADE SILICONE SHEETING FOR OBSTETRICAL & GYNOCOLOGY APPLICATIONS	Jun 30, 1994	Substantially Equivalent	Bioplexus Corp.
K930822	GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH	Jan 28, 1994	Substantially Equivalent	W. L. Gore & Associates, Inc.
K931936	GIANTURCO-HELFRICH HERNIS MESH	Jan 10, 1994	Substantially Equivalent	Cook, Inc.
K930669	ATRIUM POLYPROPYLENE MESH	Dec 16, 1993	Substantially Equivalent	Atrium Medical Corp.
K926478	GORE-TEK(R) SOFT TISSUE PATCH	Nov 29, 1993	Substantially Equivalent	W. L. Gore & Associates, Inc.
K931150	GORE-TEX MICRO MESH	Oct 29, 1993	Substantially Equivalent	W. L. Gore & Associates, Inc.
K926565	GORE-TEX(TM) DUAL MESH	Sep 09, 1993	Substantially Equivalent	W. L. Gore & Associates, Inc.
K925148	AUTO SUTURE SURGICAL MESH DEPLOYER	Feb 12, 1993	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K924749	TRELEX MESH	Nov 23, 1992	Substantially Equivalent	Meadox Medicals, Div. Boston Scientific Corp.
K922916	BARD MARLEX MESH DART	Aug 24, 1992	Substantially Equivalent	C.R. Bard, Inc.
K915526	COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH	May 29, 1992	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K914449	GORE-TEX(R) SOFT TISSUE PATCH, PROCESS CHANGE	Dec 04, 1991	Substantially Equivalent	W. L. Gore & Associates, Inc.
K905655	NONABSORBABLE POLYPROPYLENE SURGICAL MESH	Dec 31, 1990	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K840172	VENTRAL WALL DEFECT REDUCT SILO	Jun 27, 1984	Substantially Equivalent	American Heyer Schulte
K833764	STERILIZATION OF GORE-TEX SOFT TISSU	Jan 10, 1984	Substantially Equivalent	W. L. Gore & Associates, Inc.
K820193	GORE-TEX TISSUE REINFORCEMENT PATCH	Mar 26, 1982	Substantially Equivalent	W. L. Gore & Associates, Inc.
K810428	VICRYL	Mar 13, 1981	Substantially Equivalent	ETHICON, Inc.
K792281	USHER'S MARLEX TUBULAR MESH	Nov 27, 1979	Substantially Equivalent	Davol, Inc.