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.

Dressing, Wound, Drug

FDA product code FRO · 659 cleared devices

Class U Unknown

Review panel: SU
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1978-03-28 – 2026-09-22

FRO 2005-06-15

BIODERM SCIENCES WOUND HEALING SPRAY

Applicant Bioderm Sciences, Inc.

K number K042084

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FRO 2005-06-13

SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC

Applicant Noble Fiber Technologies, Inc.

K number K050649

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FRO 2005-06-09

SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)

Applicant Medline Industries, Inc.

K number K042164

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FRO 2005-06-06

COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING

Applicant Covalontechnologies, Inc.

K number K043296

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FRO 2005-05-17

DERMACYN WOUND IRRIGATION

Applicant Oculus Innovative Sciences, Inc.

K number K042729

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FRO 2005-05-17

EPI-MAX

Applicant Dermagenics, Inc.

K number K041059

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FRO 2005-05-03

MICROCYN WOUND CARE DRESSING

Applicant Oculus Innovative Sciences, Inc.

K number K041161

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FRO 2005-04-21

ACTICOAT MOISTURE CONTROL DRESSING

Applicant Smith & Nephew, Inc.

K number K050030

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FRO 2005-01-14

X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING

Applicant Noble Fiber Technologies

K number K033900

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FRO 2004-12-01

MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450

Applicant Medtrade Products , Ltd.

K number K033732

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FRO 2004-11-02

3M TEGADERM SILVER

Applicant 3M Company

K number K040890

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FRO 2004-10-27

SELECT FABRICATORS, INC., AGMED TEX WOUND DRESSING

Applicant Select Fabricators, Inc.

K number K040518

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FRO 2004-10-21

COLLAGEN-ORC ANTIMICROBIAL MATRIX

Applicant Johnson & Johnson Medical, Ltd.

K number K033523

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FRO 2004-09-07

ABRAM'S MULTI-DENSITY POLYURETHANE FOAM WOUND DRESSING SYSTEM

Applicant Dr. Len'S Medical Products, LLC

K number K033164

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FRO 2004-08-16

SILVER FOAM WOUND DRESSING

Applicant Advanced Medical Solutions, Ltd.

K number K032742

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FRO 2004-08-05

ANTIMICROBIAL ALGINATE DRESSING

Applicant Advanced Medical Solutions, Ltd.

K number K041316

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FRO 2004-08-05

SILVERSEAL

Applicant Noble Fiber Technologies

K number K033587

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FRO 2004-07-07

SUILE OINTMENT WOUND DRESSING

Applicant Hedonist Biochemical Technologies Co., Ltd.

K number K041013

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FRO 2004-06-04

BIODERM SCIENCES WOUND DRESSING

Applicant Bioderm Sciences, Inc.

K number K040683

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FRO 2004-06-01

SENSITIVE SKIN ANTIBACTERIAL BANDAGES

Applicant Scivolution, Inc.

K number K032983

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FRO 2004-05-17

CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.)

Applicant Coloplast Corp.

K number K033869

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FRO 2004-04-29

KENDALL ULTEC PRO AG+ HYDROCOLLOID DRESSING

Applicant Tyco Healthcare

K number K033453

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FRO 2004-02-10

CURAD SILVER BANDAGE

Applicant Beiersdorf AG

K number K032463

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FRO 2004-02-10

CURAD SILVER ACTIVE GEL BANDAGE

Applicant Beiersdorf AG

K number K032462

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FRO 2003-10-22

FERRIS POLYMEM SILVER WOUND DRESSING

Applicant Ferris Mfg. Corp.

K number K031307

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FRO 2003-07-08

SUILE WOUND DRESSING

Applicant Hedonist Biochemical Technologies Co., Ltd.

K number K022967

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FRO 2003-06-30

ANTIMICROBIAL ALGINATE DRESSING

Applicant Advanced Medical Solutions, Ltd.

K number K024298

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FRO 2003-03-18

SILVERLEAF CONTACT WOUND DRESSING

Applicant Silverleaf Technologies, Inc.

K number K013936

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FRO 2003-02-03

ACTISORB SILVER 220 ANTIMICROBIAL BINDING DRESSING

Applicant Johnson & Johnson Medical, Ltd.

K number K022483

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FRO 2003-02-03

CONTREET FOAM ADHESIVE/NON-ADHESIVE

Applicant Coloplast Corp.

K number K022416

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FRO 2003-02-03

SCIVOLUTIONS VARIOUS ANTIBACTERIAL BANDAGES

Applicant Scivolutions, Inc.

K number K020318

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FRO 2003-01-24

SILVERLON CONTACT WOUND DRESSING

Applicant Argentum International, LLC

K number K023612

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FRO 2003-01-17

SILVERLON ADHESIVE STRIP

Applicant Argentum International, LLC

K number K023609

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FRO 2003-01-17

HYDROFERA BACTERIOSTATIC WOUND DRESSING

Applicant Hydrofera, LLC

K number K023138

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FRO 2002-11-15

CALGITROL AG SILVER ALGINATE WOUND DRESSING

Applicant Adri

K number K011618

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FRO 2002-10-17

CARRAKLENZ AND ULTRAKLENZ

Applicant Carrington Laboratories, Inc.

K number K022670

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FRO 2002-10-17

DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414

Applicant Dynarex Corp.

K number K012816

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FRO 2002-06-21

ABSORBENT ANTIMICROBIAL WOUND DRESSING

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K013814

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FRO 2002-03-14

IALUSET HYDROCOLLOID

Applicant Institut Biochimique SA (Ibsa)

K number K020041

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FRO 2002-01-11

HYDROFERA BACTERIOSTATIC WOUND DRESSING

Applicant Hydrofera, LLC

K number K013462

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FRO 2001-09-12

ACRYDERM SILVER ANTIMICROBIAL PERFORATED WOUND DRESSING

Applicant Acrymed, Inc.

K number K012116

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FRO 2001-08-22

EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088

Applicant The Kendall Company

K number K011941

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FRO 2001-06-11

ISLAND WOUND DRESSING WITH MICROBAN

Applicant Island Dressing, LLC

K number K010951

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FRO 2001-03-27

ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING

Applicant Maersk Medical, Ltd.

K number K004028

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FRO 2001-03-15

MODIFICATION TO ACTICOAT FOAM DRESSING

Applicant Westaim Biomedical, Inc.

K number K010447

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FRO 2001-02-21

ACTICOAT FOAM DRESSING, ALGISITE M CALCIUM ALGINATE DRESSING

Applicant The Westaim Corp.

K number K002896

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FRO 2001-02-16

ACTICOAT COMPOSITE DRESSING

Applicant Westaim Biomedical, Inc.

K number K002466

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FRO 2000-10-13

ACRYDERM SILVER ANTIMICROBIAL STRANDS MODEL A-020103

Applicant Acrymed, Inc.

K number K002909

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FRO 2000-10-06

ACTICOAT 7 DRESSING

Applicant Westaim Biomedical, Inc.

K number K001519

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FRO 2000-09-21

MODIFICATION TO ACRYDERM SILVER ANTIMICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045

Applicant Acrymed, Inc.

K number K002599

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FRO 2000-06-07

ACTICOAT PRIMARY ANTIMICROBIAL DRESSING

Applicant Westaim Biomedical, Inc.

K number K992221

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FRO 2000-04-17

ACRYDERM SILVER ANTI-MICROBIAL WOUND DRESSING, MODELS 1041, 1042, 1043, 1044, 1045

Applicant Acrymed, Inc.

K number K991818

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FRO 2000-04-05

ACTICOAT FOAM DRESSING

Applicant Westaim Biomedical, Inc.

K number K000051

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FRO 1999-12-30

SALJET SINGLE DOSE STERILE SALINE TOPICAL SOLUTION

Applicant Winchester Laboratories, LLC

K number K993969

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FRO 1999-11-05

ANTIBACTERIAL ADHESIVE BANDAGE

Applicant William Feinstein & Associates, Inc.

K number K992817

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FRO 1999-09-24

SILVERLON WOUND PACKING STRIPS

Applicant Argentum International, LLC

K number K984210

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FRO 1999-09-17

ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING

Applicant Maersk Medical, Ltd.

K number K990810

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FRO 1999-08-12

SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN

Applicant Euromed, Inc.

K number K992363

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FRO 1999-06-29

SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA

Applicant Advanced Medical Solutions Group Plc

K number K991287

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FRO 1999-05-27

DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING

Applicant Dermaphylyx, Inc.

K number K990891

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FRO 1999-04-14

DUMEX IODOFORM PACKING STRIP

Applicant Dumex Medical Surgical Products, Ltd.

K number K990332

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FRO 1999-03-19

SILON DUAL-DRESS

Applicant Bio Med Sciences, Inc.

K number K990042

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FRO 1999-03-01

MODIFICATION OF CUTINOVA FOAM DRESSING

Applicant Beiersdorf-Jobt, Inc.

K number K984599

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FRO 1999-03-01

MODIFICATION OF CUTINOVA CAVITY DRESSING

Applicant Beiersdorf-Jobt, Inc.

K number K984597

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FRO 1999-03-01

MODIFICATION OF CUTINOVA HYDRO DRESSING

Applicant Beiersdorf-Jobt, Inc.

K number K984595

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FRO 1999-03-01

MODIFICATION OF CUTINOVA THIN DRESSING

Applicant Beiersdorf-Jobt, Inc.

K number K984593

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FRO 1999-02-22

SILVERLON ISLAND DRESSING, SILVERLON ISLAND PAD

Applicant Argentum International, LLC

K number K984208

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FRO 1999-01-28

COMPEED PSORIASIS DRESSING

Applicant Coloplast Corp.

K number K982493

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FRO 1998-12-16

BIATAIN FOAM ADHESIVE DRESSING

Applicant Coloplast Corp.

K number K983173

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FRO 1998-12-16

BIATAIN FOAM DRESSING

Applicant Coloplast Corp.

K number K983163

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FRO 1998-11-25

SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN

Applicant Euromed, Inc.

K number K983249

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FRO 1998-09-25

SILVERLON CONTACT WOUND DRESSING

Applicant Argentum International, LLC

K number K981299

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FRO 1998-05-04

DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING

Applicant Dumex Medical Surgical Products, Ltd.

K number K980777

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FRO 1998-03-05

20 ML NORMAL SALINE TOPICAL SOLUTION, 0.9% W/V SODIUM CHLORIDE

Applicant Steripak, Ltd.

K number K972185

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FRO 1998-02-13

ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING

Applicant Laboratoires Urgo S.A.

K number K974348

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FRO 1997-12-23

DUODERM HYDROACTIVE PASTE

Applicant Convatec, A Bristol-Myers Squibb Co.

K number K973807

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FRO 1997-12-23

DUODERM HYDROACTIVE DRESSING

Applicant Convatec, Ltd.

K number K973689

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FRO 1997-12-23

DUODERM CONTROL GEL FORMULA BORDER DRESSING

Applicant Convatec, Ltd.

K number K973688

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FRO 1997-12-22

DUODERM CGF CONTROL GEL FORMULA DRESSING

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K973632

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FRO 1997-12-17

COMBIDERM ACD

Applicant Convatec, A Bristol-Myers Squibb Co.

K number K973717

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FRO 1997-12-17

DUODERM EXTRA THIN CGF DRESSING

Applicant Convatec, A Bristol-Myers Squibb Co.

K number K973716

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FRO 1997-12-16

KENDALL CURITY PETROLATUM GAUZE

Applicant Kendall Healthcare Products Co. Div.Of Tyco Health

K number K973511

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FRO 1997-12-15

KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)

Applicant Kendall Healthcare Products Co. Div.Of Tyco Health

K number K973507

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FRO 1997-12-01

IT HYDROCOLLOID WITH ZINC

Applicant Innovative Technologies , Ltd.

K number K973855

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FRO 1997-07-29

ARGLAES FILM DRESSING

Applicant Maersk Medical, Ltd.

K number K970566

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FRO 1997-06-24

HYDROCOLLOID WOUND DRESSINGS

Applicant Innovative Technologies , Ltd.

K number K971126

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FRO 1997-02-07

MITRAFLEX PIGMENTED WOUND DRESSING

Applicant Polymedica Industries, Inc.

K number K964701

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FRO 1996-09-23

SURESKIN STANDARD, BORDER, AND THIN

Applicant Euromed A/S

K number K963039

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FRO 1996-09-20

SIGNALDRESS

Applicant Convatec, A Division of E.R. Squibb & Sons

K number K962590

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FRO 1995-11-29

TECNOL SALINE WET DRESSING

Applicant Tecnol Medical Products, Inc.

K number K954243

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FRO 1995-11-02

DERMAGRAN WOUND DRESSING CLEANER W/ZINC

Applicant Derma Sciences, Inc.

K number K954743

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FRO 1995-11-02

DERMAGRAN WET DRESSING (ZINC-SALINE)

Applicant Derma Sciences, Inc.

K number K954742

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FRO 1995-11-02

DERMAGRAN WOUND DRESSING

Applicant Derma Sciences, Inc.

K number K954740

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FRO 1995-11-02

DERMAGRAN HYDROPHILIC OINTMENT

Applicant Derma Sciences, Inc.

K number K954739

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FRO 1995-10-23

RECLOSABLE WOUND COVER

Applicant Hollister, Inc.

K number K954621

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FRO 1995-10-06

HOLLISTER HYDROCOLLOID WOUND DRESSING

Applicant Hollister, Inc.

K number K954235

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FRO 1995-08-16

SALINE DRESSING

Applicant Busse Hospital Disposables, Inc.

K number K952948

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FRO 1995-08-07

EX-111 WOUND DRESSING

Applicant Variseal Manufacturing Corp.

K number K952907

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FRO 1995-07-11

HOLLISTER HYDROCOLLOID WOUND DRESSINGS

Applicant Hollister, Inc.

K number K950933

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FRO 1995-06-08

ADHEROL SEPP APPLICATOR

Applicant Medi-Flex Hospital Products, Inc.

K number K952007

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