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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 2013-03-12

IODOFOAM IODOPHOR FOAM DRESSING

Applicant Progressive Wound Care Technologies, LLC

K number K122634

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FRO 2013-02-28

3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING

Applicant 3M Company

K number K123679

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FRO 2013-02-14

VASHE WOUND THERAPY SOLUTION

Applicant Puricore, Inc.

K number K123072

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FRO 2013-02-14

LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM

Applicant Huizhou Foryou Medical Devices Co., Ltd.

K number K120181

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FRO 2013-01-24

VASHE SKIN AND WOUND HYDROGEL

Applicant Puricore, Inc.

K number K123071

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FRO 2012-12-11

L.A.M. IMP WOUND GEL

Applicant Glycobiosciences, Inc.

K number K123113

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FRO 2012-12-11

NIXALL TM WOUND AND SKIN CARE

Applicant Seriously Clean, Ltd.

K number K113693

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FRO 2012-11-30

HYLATOPICPLUS LOTION

Applicant Precision Dermatology Incorporated

K number K121559

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FRO 2012-11-30

CURALINE POLYURETHANE FOAM AWC DRESSING

Applicant Curaline, Inc.

K number K121361

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FRO 2012-10-26

CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING

Applicant Medtrade Products , Ltd.

K number K120930

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FRO 2012-09-24

BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM)

Applicant Avery Dennison Belgie Bvba

K number K113836

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FRO 2012-09-06

LOUTREX TOPICAL CREAM

Applicant Acella Pharmaceuticals, LLC

K number K120730

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FRO 2012-08-28

ENLUXTRA HUMIFIBER WOUND DRESSING

Applicant Basf Venture Capital America, Inc.

K number K122297

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FRO 2012-08-13

SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER

Applicant Covalontechnologies, Inc.

K number K121819

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FRO 2012-08-08

NEUTROPHASE ANTIMICROBIAL WOUND CLEANSER

Applicant Novabay Pharmaceuticals

K number K113820

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FRO 2012-07-25

AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER

Applicant Convatec, Inc.

K number K121275

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FRO 2012-07-25

TL TRISEB CREAM

Applicant Trigen Laboratories, Inc.

K number K121134

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FRO 2012-07-09

OXYBAND WOUND DRESSING

Applicant O2s, LLC

K number K121407

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FRO 2012-06-27

POLYFIT ABSORBING ANTIMICROBIAL DRESSINGS (OTC)

Applicant Polyremedy, Inc.

K number K121522

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FRO 2012-05-31

CELVER

Applicant Cellulose Concepts, LLC

K number K111382

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FRO 2012-05-23

MANUKA FILL

Applicant Links Medical Products, Inc.

K number K121227

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FRO 2012-05-23

MANUKA IG

Applicant Links Medical Products, Inc.

K number K120976

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FRO 2012-05-04

IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER

Applicant Covalontechnologies, Inc.

K number K112549

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FRO 2012-04-20

SALINE WOUND WASH

Applicant Nanoplas, Inc.

K number K112666

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FRO 2012-04-12

CURAD ANTIBACTERIAL BANDAGE

Applicant Medline Industries, Inc.

K number K113583

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FRO 2012-04-05

BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES

Applicant Coloplast A/S

K number K120828

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FRO 2012-03-07

DEXERYL CREAM

Applicant Pierre Fabre Medical Devices

K number K113807

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FRO 2012-02-09

HPR PLUS EMOLLIENT FOAM

Applicant Prugen IP Holdings, Inc.

K number K113774

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FRO 2012-02-09

HPR EMOLLIENT FOAM

Applicant Prugen IP Holdings, Inc.

K number K113772

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FRO 2011-12-15

EXSALT T7 WOUND DRESSING

Applicant Exciton Technologies, Inc.

K number K113564

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FRO 2011-12-13

PRECISION SKIN EMULSION

Applicant Precision Dermatology Incorporated

K number K111168

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FRO 2011-12-07

3M TEGADERM MATRIX DRESSING

Applicant 3M Company

K number K110457

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FRO 2011-11-18

AVO BARRIER TOPICAL EMULSION

Applicant Trigen Laboratories, Inc.

K number K110762

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FRO 2011-09-23

CORELEADER COLLA-ALGI FIBER MODEL CAW

Applicant Coreleader Biotech Co., Ltd.

K number K111578

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FRO 2011-09-01

MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG

Applicant Medipurpose Pte. , Ltd.

K number K110062

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FRO 2011-08-19

TL-CERMIDE SKIN BARRIER EMULSION

Applicant Trigen Laboratories, Inc.

K number K110757

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FRO 2011-08-19

SONAFINE WOUND DRESSING

Applicant Stratus Pharmaceutical

K number K110172

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FRO 2011-07-27

MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY

Applicant Derma Sciences, Inc.

K number K110546

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FRO 2011-07-26

ADVANCIS ACTIVON TUBE

Applicant Advancis Medical

K number K101114

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FRO 2011-06-22

CORELEADER ALGIPLASTER MODEL AP 050501

Applicant Coreleader Biotech Co., Ltd.

K number K102942

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FRO 2011-06-16

ELTA WOUND CLEANSER

Applicant Swiss American Products, Inc.

K number K103713

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FRO 2011-06-03

EMULSION SB

Applicant Prugen IP Holdings, Inc.

K number K110732

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FRO 2011-05-20

EXSALT SD7 WOUND DRESSING

Applicant Exciton Technologies, Inc.

K number K103067

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FRO 2011-05-02

DURAFIBER AG

Applicant Smith & Nephew, Inc.

K number K103793

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FRO 2011-04-12

CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050

Applicant Coreleader Biotech Co., Ltd.

K number K102943

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FRO 2011-04-06

PRONTOSAN WOUND IRRIGATION SOLUTION

Applicant B.Braun Medical, Inc.

K number K110744

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FRO 2011-04-01

HYLATOPICPLUS CREAM

Applicant Precision Dermatology Incorporated

K number K110727

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FRO 2011-03-30

CHLORASHIELD TM ANTIMICROBIAL DRESSING

Applicant Care Fusion 213, LLC

K number K103106

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FRO 2011-03-24

MANUKATEX

Applicant Manuka Medical Limited

K number K110042

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FRO 2011-03-14

SILVER ANTIMICROBIAL WOUND GEL

Applicant Advanced Medical Solutions Limited

K number K110458

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FRO 2011-02-22

MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY

Applicant Derma Sciences, Inc.

K number K101793

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FRO 2011-02-02

PEDIACYN ATOPIC DERMATITIS HYDROGEL

Applicant Oculus Innovative Sciences, Inc.

K number K102945

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FRO 2011-02-02

HYPO CLENZ WOUND WASH MODEL 100 PPM

Applicant Nevoa Life Sciences, LLC

K number K100948

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FRO 2011-01-24

SORBACT

Applicant Abigo Medical AB

K number K100591

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FRO 2011-01-21

LOW ADHERENT AFM AG DRESSINGS

Applicant Milliken Healthcare Products, LLC

K number K103141

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FRO 2011-01-05

BIOMED WOUND CLEANSER

Applicant Biomed Laboratories, Inc.

K number K100613

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FRO 2010-12-15

ACTIVON TULLE

Applicant Calidad Solutions, Inc.

K number K101118

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FRO 2010-12-10

PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD

Applicant Tei Biosciences, Inc.

K number K100261

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FRO 2010-12-08

MANUKAHD, MANUKAHD ROPE, MANUKAHD BORDER

Applicant Manuka Medical Limited

K number K102659

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FRO 2010-11-03

OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING

Applicant Southwest Technologies, Inc.

K number K102478

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FRO 2010-11-03

PRONTOSAN ANTIMICROBIAL WOUND GEL

Applicant B.Braun Medical, Inc.

K number K101882

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FRO 2010-10-12

EXSALT WOUND DRESSING

Applicant Exciton Technologies, Inc.

K number K100580

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FRO 2010-09-15

MEPILEX BORDER AG DRESSING

Applicant Molnlycke Health Care

K number K100029

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FRO 2010-08-10

AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING

Applicant Medtrade Products Limited

K number K100693

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FRO 2010-08-09

VASHE WOUND THERAPY SYSTEM MODEL: 9000-0014

Applicant Puricore, Inc.

K number K100918

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FRO 2010-07-28

TALYMED

Applicant Marine Polymer Technologies

K number K102002

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FRO 2010-06-24

PR CREAM

Applicant Prugen IP Holdings, Inc.

K number K093159

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FRO 2010-06-24

PRUCLAIR NONSTEROIDAL CREAM

Applicant Prugen IP Holdings, Inc.

K number K093156

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FRO 2010-06-18

DRYODINE CADEXOMER-IODINE GEL

Applicant Collegium Pharmaceutical Incorporated

K number K093320

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FRO 2010-06-16

COLLAWOUND ART

Applicant Collamatrix, Inc.

K number K093351

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FRO 2010-06-11

URGOTUL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER

Applicant Laboratoires Urgo

K number K100430

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FRO 2010-06-11

URGOCELL AG, ANTIMICROBIAL WOUND DRESSING WITH SILVER

Applicant Laboratoires Urgo

K number K100429

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FRO 2010-05-20

MANUKAPLI WOUND DRESSING

Applicant Manuka Medical Limited

K number K092689

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FRO 2010-05-11

BARIREP

Applicant Gorbec Pharmaceutical Services, Inc.

K number K100839

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FRO 2010-04-13

VASHE WOUND THERAPY SOLUTION

Applicant Puricore, Inc.

K number K093697

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FRO 2010-04-08

POLY FIT + ABSORBING AND HIGH ABSORBING ANTIMICROBIAL DRESSINGS

Applicant Polyremedy, Inc.

K number K092351

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FRO 2010-04-08

POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS

Applicant Polyremedy, Inc.

K number K092348

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FRO 2010-03-08

MICROCYN SKIN AND WOUND HYDROGEL

Applicant Oculus Innovative Sciences, Inc.

K number K093585

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FRO 2010-03-01

VASHE WOUND CLEANSING SYSTEM

Applicant Puricore, Inc.

K number K093155

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FRO 2010-02-17

BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM

Applicant Coloplast A/S

K number K100218

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FRO 2010-02-17

AFM ULTRA AG DRESSINGS

Applicant Milliken & Co.

K number K093188

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FRO 2010-02-16

TROPAZONE CR

Applicant Midlothian Laboratories

K number K093544

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FRO 2010-01-26

JALOSKIN

Applicant Fidia Advanced Biopolymers Srl

K number K092257

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FRO 2010-01-21

AWBAT-S PLUS, AWBAT-D PLUS, AWBAT-M PLUS

Applicant Aubrey, Inc.

K number K091863

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FRO 2010-01-15

PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE

Applicant Prugen IP Holdings, Inc.

K number K092878

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FRO 2010-01-07

MEDLINE CURAD WOUND DRESSINGS

Applicant Medline Industries, Inc.

K number K093349

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FRO 2010-01-07

MENDASIL TWG GEL ANTIMICROBIAL SKIN AND WOUND GEL

Applicant Conseal International, Inc.

K number K090345

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FRO 2009-12-16

AQUACEL AG SURGICAL

Applicant Convatec

K number K091034

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FRO 2009-12-10

SILVERSTREAM AND DERMASEPT

Applicant Enzysurge , Ltd.

K number K093227

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FRO 2009-12-07

HYLATOPIC PLUS EMOLLIENT FOAM

Applicant Collegium Pharmaceutical Incorporated

K number K093051

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FRO 2009-11-12

ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL

Applicant American Biotech Labs

K number K092826

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FRO 2009-10-30

SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS

Applicant Andover Healthcare, Inc.

K number K083133

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FRO 2009-10-21

ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING

Applicant Acrymed, Inc.

K number K091354

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FRO 2009-10-09

ELETONE CREAM

Applicant Ferndale Pharma Group, Inc.

K number K092297

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FRO 2009-09-04

SILVER IMPREGNATED HYDROFIBER DRESSING REINFORCED WITH NYLON (FLAT)

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

K number K090254

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FRO 2009-08-19

MODIFICATION TO:VASHE WOUND CLEANSING SYSTEM, MODEL 9000-0014

Applicant Puricore, Inc.

K number K092232

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FRO 2009-08-13

TROPAZONE LOTION

Applicant Midlothian Laboratories

K number K090337

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FRO 2009-08-13

TT-102

Applicant Tissue Technologies Holdings, LLC

K number K081246

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FRO 2009-08-07

DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%

Applicant Century Pharmaceuticals, Inc.

K number K090791

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FRO 2009-07-30

NEOSALUS LOTION

Applicant Quinnova Pharmaceuticals

K number K091719

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