Mesh, Surgical, Polymeric

FDA product code FTL · 313 cleared devices

Class 2 General, Plastic Surgery

Regulation: 21 CFR 878.3300
Review panel: SU
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1979-11-27 – 2026-05-21

FTL 2026-05-21

ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)

Applicant Sofradim Production

K number K253956

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FTL 2025-10-24

Parietene™ Flat Sheet Mesh

Applicant Medtronic - Sofradim Production

K number K253125

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FTL 2025-07-24

Onflex™ Mesh

Applicant Davol Inc., Subsidiary of C. R. Bard, Inc.

K number K251955

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FTL 2025-06-12

Bard® Mesh; Bard® Mesh Pre-Shaped

Applicant Davol, Inc.

K number K251557

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FTL 2025-04-23

Parietene™ Macroporous Mesh (PPM5050 )

Applicant Sofradim Production

K number K250869

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FTL 2025-04-09

Bard Soft Mesh; Bard Soft Mesh Pre-Shaped

Applicant Davol, Inc.

K number K250098

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FTL 2025-01-17

ProGrip™ Self-Gripping Polypropylene Mesh

Applicant Sofradim Production

K number K243315

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FTL 2024-06-14

3DMax Light Mesh

Applicant Davol Inc., Subsidiary of C. R. Bard, Inc.

K number K241250

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FTL 2024-01-18

Progrip™ Self-Gripping Polypropylene Mesh

Applicant Sofradim Production

K number K232373

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FTL 2023-11-01

Bard 3DMax Mesh

Applicant Davol Inc., Subsidiary of C. R. Bard, Inc.

K number K233402

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FTL 2023-10-18

T-Line® Hernia Mesh

Applicant Deep Blue Medical Advances, Inc.

K number K232924

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FTL 2023-05-31

Pitch PaSoft Tissue Reinforcement Device

Applicant Xiros, Ltd.

K number K230671

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FTL 2023-02-23

T-Line Hernia Mesh

Applicant Deep Blue Medical Advances, Inc.

K number K230227

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FTL 2022-12-02

Parietene Macroporous Mesh

Applicant Sofradim Production

K number K223218

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FTL 2022-11-28

T-Line Hernia Mesh

Applicant Deep Blue Medical Advances, Inc.

K number K221556

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FTL 2022-09-22

ProGrip Self-Gripping Polypropylene Mesh

Applicant Covidien

K number K220540

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FTL 2022-08-26

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device

Applicant Xiros, Ltd.

K number K220091

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FTL 2022-06-22

Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh

Applicant Sofradim Production

K number K220586

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FTL 2022-03-18

ARISTE AB Mesh

Applicant Ariste Medical, LLC

K number K211132

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FTL 2021-08-13

Pitch-Patchs

Applicant Xiros, Ltd.

K number K211563

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FTL 2021-01-07

SurgiWrap FROST

Applicant Mast Biosurgery

K number K200918

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FTL 2020-08-06

VICRYL Mesh

Applicant ETHICON, Inc.

K number K201143

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FTL 2020-07-17

3DMax MID Anatomical Mesh

Applicant C.R. Bard, Inc.

K number K200818

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FTL 2020-04-08

TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)

Applicant Medtronic, Inc.

K number K192636

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FTL 2020-03-30

T-Line Hernia Mesh

Applicant Deep Blue Medical Advances, Inc.

K number K193144

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FTL 2020-03-27

TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)

Applicant Medtronic, Inc.

K number K192389

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FTL 2019-12-06

Dextile Anatomical Mesh

Applicant Sofradim Production

K number K192443

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FTL 2019-10-22

VICRYL Mesh

Applicant ETHICON, Inc.

K number K191373

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FTL 2019-09-27

FlexBand Plus

Applicant International Life Sciences

K number K192112

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FTL 2019-09-26

Exogenesis Hernia Mesh

Applicant Exogenesis Corporation

K number K191545

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FTL 2018-12-14

Phasix ST Mesh with Echo 2 Positioning System

Applicant C.R. Bard, Inc.

K number K182008

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FTL 2018-12-04

Endoform Reconstructive Template - Non Absorbable

Applicant Aroa Biosurgery , Ltd.

K number K181935

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FTL 2018-10-31

DynaMesh-POSTERIOR

Applicant Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft

K number K182087

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FTL 2018-08-02

Polydioxanone Surgical Scaffold

Applicant Lntegra Lifesciences

K number K181094

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FTL 2018-07-26

PROLENE (Polypropylene) 3D Patch

Applicant ETHICON, Inc.

K number K181268

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FTL 2018-07-02

ULTRAPRO Mesh and ULTRAPRO ADVANCED

Applicant ETHICON, Inc.

K number K180910

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FTL 2018-06-28

PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh

Applicant ETHICON, Inc.

K number K180829

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FTL 2018-06-07

TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)

Applicant Medtronic, Inc.

K number K180122

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FTL 2018-04-30

VitaMESH Macroporous PP Surgical Mesh

Applicant Proxy Biomedical , Ltd.

K number K172636

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FTL 2018-04-24

TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)

Applicant Medtronic, Inc.

K number K180030

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FTL 2018-03-09

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)

Applicant Sofradim Production

K number K173796

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FTL 2018-02-01

Duatene bilayer mesh

Applicant Sofradim Production

K number K172395

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FTL 2017-10-05

PROLENE Soft Polypropylene Mesh

Applicant ETHICON, Inc.

K number K172089

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FTL 2017-08-09

Reperen Surgical Mesh

Applicant Iconlab, Inc.

K number K170134

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FTL 2017-06-29

Parietene DS Composite Mesh

Applicant Sofradim Production

K number K163212

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FTL 2017-05-11

GORE SYNECOR Preperitoneal Biomaterial

Applicant W. L. Gore & Associates, Inc.

K number K163576

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FTL 2017-05-01

VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4”x 6”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6”x8”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6”x10”) Oval

Applicant C. R. Bard

K number K170294

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FTL 2017-03-11

PROLENE Soft Polypropylene Mesh

Applicant ETHICON, Inc.

K number K163152

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FTL 2016-12-22

DynaMesh-VENTRAL

Applicant Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft

K number K161550

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FTL 2016-06-16

Endoform Reconstructive Template

Applicant Aroa Biosurgery Limited (Formerly Mesynthes Limited)

K number K153632

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FTL 2016-05-13

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

Applicant C.R. Bard, Inc.

K number K153236

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FTL 2013-12-13

BARD VENTRALEX HERNIA PATCH

Applicant C.R. Bard, Inc.

K number K132441

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FTL 2013-11-26

AIGIS RX N (MEDIUM), AIGIS RX N (LARGE)

Applicant Tyrx, Inc.

K number K132699

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FTL 2013-10-25

COVAMESH

Applicant Biomup S.A.

K number K130428

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FTL 2013-10-23

DYNAMESH -CICAT

Applicant Feg Textiltechnik Forschungs-Und Entwicklungsgesel

K number K131530

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FTL 2013-08-22

SYMBOTEX(TM) COMPOSITE MESH

Applicant Sofradim Production

K number K131969

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FTL 2013-07-10

AIGIS RX N MEDIUM; AIGIS RX N LARGE

Applicant Tyrx, Inc.

K number K131007

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FTL 2013-05-20

AIGIS RX R PM/ AIGIS RX R ICD

Applicant Tyrx, Inc.

K number K130943

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FTL 2013-05-01

VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM

Applicant C.R. Bard, Inc.

K number K130968

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FTL 2012-12-13

MEDLINX SURGICAL MESH

Applicant Medlinx Acala Pte, Ltd.

K number K120844

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FTL 2012-12-11

PROGRIP LAPAROSCOPIC SELF-FIXATING MESH

Applicant Sofradim Production

K number K123479

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FTL 2012-11-02

COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM

Applicant C.R. Bard, Inc.

K number K122436

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FTL 2012-08-23

FREEDOM INGUINAL HERNIA IMPLANT

Applicant Insightra Medical

K number K113552

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FTL 2012-07-20

VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING

Applicant C.R. Bard, Inc.

K number K113229

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FTL 2012-07-17

TIO2MESH TM

Applicant Biocer Entwicklungs GmbH

K number K113311

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FTL 2012-06-29

PROGRIP LAPARSCOPIC SELF-FIXATING MESH

Applicant Sofradim Production

K number K120897

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FTL 2012-06-26

SURGIMESH XB - SKIRTED

Applicant Aspide Medical

K number K120025

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FTL 2012-06-13

PARIETEX COMPOSITE VENTRAL PATCH

Applicant Sofradim Production

K number K120506

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FTL 2012-04-26

C-QUR RPM MESH

Applicant Atrium Medical Corp.

K number K121070

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FTL 2012-04-02

HYBRID GRAFT

Applicant Cook Biotech, Inc.

K number K111695

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FTL 2012-01-25

TORNIER COLLAGEN COATED BIOFIBER SCAFFOLD

Applicant Tornier, Inc.

K number K111337

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FTL 2011-12-23

BIOMERIX ASSURE

Applicant Biomerix Corporation

K number K112567

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FTL 2011-12-23

BIOMERIX COMPOSITE SURGICAL MESH

Applicant Biomerix Corporation

K number K112499

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FTL 2011-11-22

RENASYS AB ABOMINAL DRESSING KIT

Applicant Smith & Nephew, Inc.

K number K112784

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FTL 2011-08-11

PAIRETEX OPTIMIZED COMPOSITE MESH (PCO-FX REFRENCES)

Applicant Sofradim Production

K number K110663

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FTL 2011-06-14

HYDROFIX SURGICAL SHEET

Applicant Mimedx Group, Inc.

K number K100313

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FTL 2011-05-13

VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH

Applicant Proxy Biomedical , Ltd.

K number K111121

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FTL 2011-05-10

TORNIER BIOFIBER SCAFFOLD

Applicant Tornier, Inc.

K number K102788

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FTL 2011-04-19

PARIETEX OPTIMIZED COMPOSITE MESH (PCO-OSX REFERENCES)

Applicant Sofradim Production

K number K110816

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FTL 2011-04-19

PARIETEX OPTIMIZED COMPOSTIE MESH

Applicant Sofradim Production

K number K110815

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FTL 2011-04-01

VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM

Applicant C.R. Bard, Inc.

K number K110820

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FTL 2011-03-23

VENTRALEX ST HERNIA PATCH

Applicant C.R. Bard, Inc.

K number K101928

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FTL 2011-03-23

VENTRIO ST HERNIA PATCH

Applicant C.R. Bard, Inc.

K number K101920

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FTL 2011-03-04

PARIETEX PROGRIP

Applicant Sofradim Production

K number K103682

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FTL 2011-02-22

ALACER SURGICAL SCAFFOLD

Applicant Alacer Biomedical, Inc.

K number K103445

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FTL 2011-02-15

ATRIUM CENTRILFX MESH

Applicant Atrium Medical Corporation

K number K110110

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FTL 2010-12-22

RESTORELLE POLYPROPYLENE MESH; RESTORELLE POLYPROPYLENE MESH

Applicant Coloplast A/S

K number K103568

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FTL 2010-12-16

COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM

Applicant C.R. Bard, Inc.

K number K102766

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FTL 2010-11-05

PARIETEX PLUG AND PATCH

Applicant Sofradim Production

K number K101519

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FTL 2010-09-17

RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT

Applicant Smith & Nephew, Inc.

K number K100787

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FTL 2010-08-16

ASCEND BLUE AC MESH; ASCEND BLUE PC MESH

Applicant Caldera Medical, Inc.

K number K101462

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FTL 2010-07-15

VENTRALIGHT ST MESH

Applicant Davol Inc., Sub. C. R. Bard, Inc.

K number K101851

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FTL 2010-06-25

BIOMESH CA.B.S. 'AIR COMPOSITE, MODELS: CABST1R05T, CABSAIRC7, CABSAIRC09

Applicant Cousin Biotech Sas

K number K093196

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FTL 2010-06-25

SURGIMESH XD

Applicant Aspide Medical

K number K092233

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FTL 2010-05-13

BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB

Applicant Biomerix Corporation

K number K093123

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FTL 2010-05-05

PARIE TENE PROGRIP MESH

Applicant Sofradim Production

K number K101197

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FTL 2010-04-22

TORNIER SURGICAL MESH

Applicant Tornier, Inc.

K number K093799

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FTL 2010-04-21

VENTRIO HERNIA PATCH

Applicant C.R. Bard, Inc.

K number K100229

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FTL 2010-04-09

ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH

Applicant Ethicon GmbH

K number K093932

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FTL 2010-03-26

PIVIT A/B ST AND PIVIT A/B ST-R

Applicant Tyrx, Inc.

K number K093524

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