Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Mesh, Surgical

FDA product code FTM · 152 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: 1982-05-14 – 2026-08-12

FTM 2026-08-12

EluPro Antibiotic-Eluting BioEnvelope

Applicant Boston Scientific

K number K262406

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FTM 2025-06-03

Endoform Reconstructive Template - PLGA

Applicant Aroa Biosurgery , Ltd.

K number K250598

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FTM 2024-12-19

OviTex PRS (Long-Term Resorbable)

Applicant TELA Bio, Inc.

K number K243595

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FTM 2024-06-14

CanGaroo RM Antibacterial Envelope

Applicant Elutia, Inc.

K number K233991

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FTM 2024-05-22

OviTex PRS

Applicant TELA Bio, Inc.

K number K241126

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FTM 2023-04-07

Peri-Guard and Supple Peri-Guard

Applicant Synovis Life Technologies, Inc.

K number K223052

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FTM 2023-03-21

OviTex PRS (Long Term Resorbable)

Applicant Tela Bio

K number K214070

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FTM 2021-10-29

VersaWrap

Applicant Alafair Biosciences, Inc.

K number K213163

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FTM 2021-10-27

PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology

Applicant Synovis Life Technologies. Inc. (A Subsidiary of Baxter

K number K213125

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FTM 2021-07-14

Nexo-Gide Bilayer Collagen Membrane

Applicant Geistlich Pharma AG

K number K203496

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FTM 2021-03-09

VersaWrap

Applicant Alafair Biosciences, Inc.

K number K203600

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FTM 2020-09-03

Lyograft

Applicant B. Bruan Surgical, SA

K number K192452

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FTM 2020-07-13

Biodesign Staple Line Reinforcement

Applicant Cook Biotech Incorporated

K number K201000

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FTM 2020-06-15

CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)

Applicant Aziyo Biologics, Inc.

K number K201313

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FTM 2020-03-06

VersaWrap Tendon Protector

Applicant Alafair Biosciences, Inc.

K number K200311

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FTM 2019-12-17

Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)

Applicant Synovis Life Technologies, Inc. (Baxter International Inc.)

K number K192615

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FTM 2019-10-21

CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ)

Applicant Aziyo Biologics, Inc.

K number K192616

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FTM 2019-06-18

Bovine Pericardial Tissue Patch

Applicant Tisgenx

K number K182493

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FTM 2019-04-11

Endoform Restella

Applicant Aroa Biosurgery , Ltd.

K number K183398

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FTM 2019-03-13

DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional

Applicant Synthes (USA) Products, LLC

K number K183472

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FTM 2019-02-07

Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal

Applicant Acell, Inc.

K number K182259

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FTM 2018-11-15

CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large)

Applicant Aziyo Biologics, Inc.

K number K182255

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FTM 2018-03-13

Biodesign Diaphragmatic Hernia Graft

Applicant Cook Biotech Incorporated

K number K171817

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FTM 2017-10-25

CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large)

Applicant Aziyo Biologics, Inc.

K number K173242

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FTM 2017-10-25

Colorado Therapeutics Xenograft Implant

Applicant Colorado Therapeutics, LLC

K number K172937

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FTM 2017-07-10

Biodesign Parastomal Hernia Repair Graft

Applicant Cook Biotech Incorporated

K number K162934

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FTM 2017-06-21

Biodesign Fistula Plug

Applicant Cook Biotech Incorporated

K number K170016

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FTM 2017-06-08

Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend

Applicant Acell, Inc.

K number K170763

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FTM 2017-02-24

ARTIA Reconstructive Tissue Matrix Perforated

Applicant Lifecell Corporation

K number K162752

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FTM 2017-02-16

SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction

Applicant Tei Biosciences, Inc.

K number K162965

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FTM 2017-02-16

Miromatrix Biological Mesh TW

Applicant Miromatrix Medical, Inc.

K number K162570

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FTM 2017-02-03

CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)

Applicant Curaseal, Inc.

K number K162388

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FTM 2016-12-20

Endoform Plastics and Reconstructive Matrix

Applicant Aroa Biosurgery (Formerly Mesynthes Limited)

K number K162461

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FTM 2016-10-21

Gentrix Surgical Matrix

Applicant Acell, Inc.

K number K162554

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FTM 2016-10-20

COLORADO THERAPEUTICS XENOGRAFT IMPLANT

Applicant Colorado Therapeutics, LLC

K number K160181

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FTM 2016-05-26

Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug

Applicant Cook Biotech Incorporated

K number K161221

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FTM 2016-04-29

Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft

Applicant Cook Biotech Incorporated

K number K160869

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FTM 2016-03-15

Endoform Reconstructive Template

Applicant Aroa Biosurgery Limited (Formerly Mesynthes Limited)

K number K153633

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FTM 2016-03-08

SurgiPure XD Reconstructive Tissue Matrix

Applicant Tissue Regenix Group Plc

K number K152206

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FTM 2013-10-30

MESO BILAYER SURGICAL MESH

Applicant Kensey Nash Corporation Dba Dsm Biomedical

K number K132025

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FTM 2013-05-31

ENDOFORM RECONSTRUCTIVE TEMPLATE

Applicant Mesynthe, Ltd.

K number K130547

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FTM 2013-03-05

FORTIVA PORCINE DERMIS

Applicant Rti Biologics, Inc.

K number K123356

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FTM 2013-01-08

COLLAGEN TENDON SHEET-D

Applicant Rotation Medical, Inc.

K number K122048

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FTM 2012-05-18

PERMACOL SURGICAL IMPLANT

Applicant Covidien, LLC

K number K120605

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FTM 2012-02-23

COLLAGEN RIBBON

Applicant Wrightmedicaltechnologyinc

K number K120019

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FTM 2012-01-11

SYNERGY TISSUE MATRIX

Applicant Synovis Orthopedic & Woundcare

K number K113460

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FTM 2012-01-10

PROPATCH SOFT TISSUE REPAIR MATRIX

Applicant Cryolife, Inc.

K number K110581

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FTM 2011-12-22

COLLAGEN TENDON SHEET

Applicant Rotation Medical, Inc.

K number K112423

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FTM 2011-10-25

PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF

Applicant Synovis Orthopedic and Woundcare, Inc.

K number K112786

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FTM 2011-10-14

PORCINE SURGICAL MESH, PORCINE DERMAL MATRIX

Applicant Brennen Medical, LLC

K number K111436

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FTM 2011-08-25

XYLOS MACRO-POROUS SURGICAL MESH

Applicant Xylos Corporation

K number K111584

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FTM 2011-06-20

BIODESIGN NIPPLE RECONSTRUCTION CYLINDER

Applicant Cook Biotech, Inc.

K number K110402

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FTM 2011-02-07

MEDEOR MATRIX

Applicant Kensey Nash Corp.

K number K103787

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FTM 2010-09-16

PROPATCH SOFT TISSUE REPAIR MATRIX

Applicant Cryolife, Inc.

K number K101587

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FTM 2010-05-18

KENSEY NASH ECM SURGICAL PATCH

Applicant Kensey Nash Corporation

K number K094061

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FTM 2009-10-22

MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)

Applicant Kensey Nash Corp.

K number K091499

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FTM 2009-08-31

TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358

Applicant Rti Biologics, Inc.

K number K091142

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FTM 2009-05-27

XYLOS POROUS SURGICAL MESH

Applicant Xylos Corporation

K number K090880

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FTM 2009-04-28

MTA PROTECTIVE SHEET

Applicant Xylos Corporation

K number K090778

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FTM 2009-03-18

SECURIAN TISSUE REINFORCEMENT MATRIX

Applicant Xylos Corporation

K number K083823

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FTM 2009-02-27

SURGISIS BIODESIGN ENTEROCUTANEOUS FISTULA PLUG

Applicant Cook Biotech, Inc.

K number K082682

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FTM 2009-02-04

SURGIMEND

Applicant Tei Biosciences, Inc.

K number K083898

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FTM 2008-11-26

VERITAS COLLAGEN MATRIX (DRY)

Applicant Synovis Surgical Innovations

K number K083039

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FTM 2008-11-14

LTM-BPS SURGICAL MESH

Applicant Lifecell Corp.

K number K082176

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FTM 2008-10-17

COLLAMEND FM IMPLANT

Applicant C.R. Bard, Inc.

K number K082687

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FTM 2008-07-31

PORCINE SURGICAL MESH; DERMAL MATRIX

Applicant Brennen Medical, LLC

K number K081272

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FTM 2008-07-11

MODIFICATION TO XYLOS SURGICAL MESH

Applicant Xylos Corporation

K number K081882

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FTM 2008-06-19

TUTOPATCH, TUTOMESH

Applicant Rti Biologics, Inc.

K number K081538

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FTM 2008-05-15

COLLAGEN TENDON WRAP

Applicant Collagen Matrix, Inc.

K number K080452

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FTM 2008-04-10

WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08

Applicant American Medical Systems, Inc.

K number K073219

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FTM 2008-03-21

SURGISIS BIODESIGN TISSUE GRAFT

Applicant Cook Biotech, Inc.

K number K073391

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FTM 2007-10-19

LTM-RC SURGICAL MESH

Applicant Lifecell Corp.

K number K071986

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FTM 2007-10-17

MODIFICATION TO SURGISIS SLR STAPLE LINE REINFORCEMENT

Applicant Cook Biotech, Inc.

K number K070405

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FTM 2007-09-04

DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT

Applicant DePuy Orthopaedics, Inc.

K number K071016

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FTM 2007-08-06

ORTHOMEND SOFT TISSUE MATRIX

Applicant Tei Biosciences, Inc.

K number K071807

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FTM 2007-06-20

MESOSFOL SURGICAL FILM

Applicant Biomet Manufacturing Corp

K number K062558

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FTM 2007-06-11

LRTM SURGICAL MESH

Applicant Lifecell Corp.

K number K070560

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FTM 2007-05-04

ORTHADAPT BIOIMPLANT

Applicant Pegasus Biologics, Inc.

K number K071065

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FTM 2007-04-05

SIS FACIAL CYLINDER, SIS FACIAL IMPLANT

Applicant Cook Biotech, Inc.

K number K070738

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FTM 2007-03-20

PERIPATCH ENDO-SLEEVE

Applicant Pm Devices, Inc.

K number K063556

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FTM 2006-12-06

VERITAS COLLAGEN MATRIX

Applicant Synovis Surgical Innovations

K number K062915

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FTM 2006-11-22

PROPATCH SOFT TISSUE REPAIR MATRIX

Applicant Cryolife, Inc.

K number K061892

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FTM 2006-11-21

BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106

Applicant C.R. Bard, Inc.

K number K063178

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FTM 2006-10-13

SURGISIS, SURGISIS ES

Applicant Cook Biotech, Inc.

K number K062696

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FTM 2006-10-10

SURGISIS RVP RECTO-VAGINAL FISTULA PLUG

Applicant Cook Biotech, Inc.

K number K062729

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FTM 2006-10-02

SURGISIS PEYRONIE'S REPAIR GRAFT, MODEL SPR-100

Applicant Cook Biotech, Inc.

K number K062320

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FTM 2006-06-23

ZIMMER COLLAGEN REPAIR PATCH

Applicant Tissue Science Laboratories, Plc

K number K053562

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FTM 2006-05-17

XENFORM SOFT TISSUE REPAIR MATRIX

Applicant Tei Biosciences, Inc.

K number K060984

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FTM 2006-05-17

COSMATRIX

Applicant Tei Biosciences, Inc.

K number K060829

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FTM 2006-05-15

TISSUEMEND SOFT TISSUE REPAIR MATRIX

Applicant Tei Biosciences, Inc.

K number K060989

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FTM 2006-05-09

BIOBLANKET SURGICAL MESH

Applicant Kensey Nash Corporation

K number K061030

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FTM 2006-04-10

BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 1175104, 1175105

Applicant C.R. Bard, Inc.

K number K052322

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FTM 2006-02-03

TENDON WRAP TENDON PROTECTOR

Applicant Integra LifeSciences Corporation

K number K053655

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FTM 2005-10-05

SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS

Applicant Synthes (Usa)

K number K051879

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FTM 2005-09-23

SURGISIS STAPLE LINE REINFORCEMENT II

Applicant Cook Biotech, Inc.

K number K051048

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FTM 2005-08-15

BIOBLANKET SURGICAL MESH

Applicant Kensey Nash Corp.

K number K043259

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FTM 2005-08-05

PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH

Applicant Pegasus Biologics, Inc.

K number K043388

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FTM 2005-05-19

SIS DERMAL AUGMENTATION STRAND

Applicant Cook Biotech, Inc.

K number K050246

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FTM 2005-03-09

SIS FISTULA PLUG

Applicant Cook Biotech, Inc.

K number K050337

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FTM 2004-11-02

CUFFPATCH

Applicant Organogenesis, Inc.

K number K042809

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