FDA 510(k) Applications for Medical Device Product Code "MGP"
(Dressing, Wound And Burn, Occlusive)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K973036 | 3M HEALTH CARE | 3M TEGADERM TRANSPARENT DRESSING, 3M TEGADERM TRANSPARENT DRESSING (FIRST AID DELIVERY), 3M TEGADERM HP TRANSPARENT DRES | 11/12/1997 |
| K974892 | ACUTEK ADHESIVE SPECIALTIES, INC. | ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197012 | 10/13/1998 |
| K974891 | ACUTEK ADHESIVE SPECIALTIES, INC. | ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 197013 | 10/21/1998 |
| K974890 | ACUTEK ADHESIVE SPECIALTIES, INC. | ACUTEK'S HYDROCOLLOID WOUND DRESSING, TIB 997002 | 10/13/1998 |
| K991287 | ADVANCED MEDICAL SOLUTIONS GROUP PLC | SPYROGEL HYDROGEL WOUND AND BURN DRESSING SA | 06/29/1999 |
| K973260 | AVITAR, INC. | HYDRASORB STERILE DRESSING | 10/21/1997 |
| K960847 | BELLINGHAM MEDICAL, INC. | DERMASEAL | 04/04/1996 |
| K990042 | BIO MED SCIENCES, INC. | SILON DUAL-DRESS | 03/19/1999 |
| K012997 | BIOCORE MEDICAL TECHNOLOGIES, INC. | COLLATEK FOAM | 10/25/2001 |
| K012995 | BIOCORE MEDICAL TECHNOLOGIES, INC. | COLLATEK SHEET | 10/25/2001 |
| K982939 | BIODERM, INC. | BTF THIN FILM WOUND DRESSING | 10/13/1998 |
| K983173 | COLOPLAST CORP. | BIATAIN FOAM ADHESIVE DRESSING | 12/16/1998 |
| K983163 | COLOPLAST CORP. | BIATAIN FOAM DRESSING | 12/16/1998 |
| K982493 | COLOPLAST CORP. | COMPEED PSORIASIS DRESSING | 01/28/1999 |
| K973688 | CONVATEC LTD. | DUODERM CONTROL GEL FORMULA BORDER DRESSING | 12/23/1997 |
| K973689 | CONVATEC LTD. | DUODERM HYDROACTIVE DRESSING | 12/23/1997 |
| K973717 | CONVATEC, A BRISTOL-MYERS SQUIBB CO. | COMBIDERM ACD | 12/17/1997 |
| K973716 | CONVATEC, A BRISTOL-MYERS SQUIBB CO. | DUODERM EXTRA THIN CGF DRESSING | 12/17/1997 |
| K973807 | CONVATEC, A BRISTOL-MYERS SQUIBB CO. | DUODERM HYDROACTIVE PASTE | 12/23/1997 |
| K973632 | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS | DUODERM CGF CONTROL GEL FORMULA DRESSING | 12/22/1997 |
| K961319 | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS | EPIVIEW | 07/08/1996 |
| K962590 | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS | SIGNALDRESS | 09/20/1996 |
| K972458 | COURTAULDS FIBERS, INC. | LYOCELL WOUND DRESSING/SURGICAL SPONGE | 09/19/1997 |
| K990438 | DERMAPHYLYX, INC. | DERMAFLEX WOUND DRESSING, DERMAFLEX FOAM WOUND DRESSING, HEALIAFLEX WOUND DRESSING, HEALIAFOAM WOUND DRESSING | 03/25/1999 |
| K990875 | DERMAPHYLYX, INC. | DERMAPHYLYX FILM WOUND DRESSING AND HEALIAN FILM WOUND DRESSING | 05/27/1999 |
| K990891 | DERMAPHYLYX, INC. | DERMAPHYLYX HYDROCOLLOID WOUND DRESSING, HEALIAN HYDROCOLLOID WOUND DRESSING | 05/27/1999 |
| K992302 | DERMAPHYLYX, INC. | DERMAPHYLYX SKIN PROTECTORS, PROTECT IT SKIN PROTECTORS | 09/14/1999 |
| K955476 | DUKAL CORP. | DUKAL TRANSPARENT WOUND DRESSING | 01/18/1996 |
| K980777 | DUMEX MEDICAL SURGICAL PRODUCTS, LTD. | DUMEX PAK-ITS-ABSORBASALT COTTON GAUZE PACKING | 05/04/1998 |
| K960393 | EUROMED A/S | SURESKIN BORDER | 03/01/1996 |
| K960394 | EUROMED A/S | SURESKIN STANDARD | 03/01/1996 |
| K963039 | EUROMED A/S | SURESKIN STANDARD, BORDER, AND THIN | 09/23/1996 |
| K960404 | EUROMED A/S | SURESKIN THIN | 03/01/1996 |
| K992363 | EUROMED, INC. | SURESKIN II STANDARD, SURESKIN II BORDER, SURESKIN II THIN | 08/12/1999 |
| K983249 | EUROMED, INC. | SURESKIN PLUS STANDARD, SURESKIN PLUS BORDER, SURESKIN PLUS THIN | 11/25/1998 |
| K001508 | FIDIA ADVANCED BIOPOLYMERS SRL | LASERSKIN DRESSING | 07/25/2001 |
| K992005 | GILTECH PLUS, INC. | GILTECH PLUS TRANSPARENT DRESSING | 09/03/1999 |
| K990079 | GREENFIELD MEDICAL TECHNOLOGIES, INC. | FASTSEAL CHEST WOUND DRESSING | 12/23/1999 |
| K980209 | HOLLISTER, INC. | SIMPLICARE THIN FILM WOUND DRESSINGS | 02/20/1998 |
| K991214 | HOLLISTER, INC. | SIMPLICARE TRANSPARENT WOUND DRESSING | 10/14/1999 |
| K974520 | INNOVATIVE TECHNOLOGIES (US), INC. | SPYROFLEX FOAM ISLAND WOUND DRESSING, SPYROFLEX FOAM ISLAND WOUND DRESSING, TINTED, SPYROFOAM | 02/06/1998 |
| K971126 | INNOVATIVE TECHNOLOGIES LTD. | HYDROCOLLOID WOUND DRESSINGS | 06/24/1997 |
| K983303 | INNOVATIVE TECHNOLOGIES LTD. | INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGS | 12/09/1998 |
| K981753 | INNOVATIVE TECHNOLOGIES LTD. | INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSING | 06/30/1998 |
| K973855 | INNOVATIVE TECHNOLOGIES LTD. | IT HYDROCOLLOID WITH ZINC | 12/01/1997 |
| K973312 | INNOVATIVE TECHNOLOGIES LTD. | TRANSPARENT FILM DRESSING, INTELLIGENT FILM DRESSING | 10/22/1997 |
| K010951 | ISLAND DRESSING, LLC. | ISLAND WOUND DRESSING WITH MICROBAN | 06/11/2001 |
| K983394 | JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. | MODIFICATION TO TIELLE HYDROPOLMER DRESSING | 11/03/1998 |
| K983234 | JOHNSON & JOHNSON MEDICAL, DIV. OF ETHICON, INC. | TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING | 11/25/1998 |
| K961098 | K. W. GRIFFEN CO. | BIO-DRESSING, STERILE ISLAND DRESSING | 05/03/1996 |
| K974348 | LABORATOIRES URGO S.A. | ALGOPLAQUE FILM EXTRA THIN HYDROCOLLOID DRESSING | 02/13/1998 |
| K970518 | LABORATOIRES URGO S.A. | ALGOPLAQUE HYDROCOLLOID DRESSING | 03/21/1997 |
| K970566 | MAERSK MEDICAL, LTD. | ARGLAES FILM DRESSING | 07/29/1997 |
| K973657 | MAERSK MEDICAL, LTD. | ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING | 12/01/1997 |
| K990810 | MAERSK MEDICAL, LTD. | ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING | 09/17/1999 |
| K004028 | MAERSK MEDICAL, LTD. | ARGLAES-AB ANTIMICROBIAL BARRIER POWDER DRESSING | 03/27/2001 |
| K983184 | MOLNLYCKE HEALTH CARE, INC. | MEPILEX | 10/28/1998 |
| K984371 | MOLNLYCKE HEALTH CARE, INC. | MEPITEL NON ADHERENT SILICONE DRESSING | 03/03/1999 |
| K963753 | NORTH AMERICAN STERILIZATION & PACKAGING CO. | NASP TRANSPARENT DRESSING | 11/29/1996 |
| K971093 | OPPORTUNITY, INC. | OPPORTUNITY I.V. START KIT | 09/16/1997 |
| K964701 | POLYMEDICA INDUSTRIES, INC. | MITRAFLEX PIGMENTED WOUND DRESSING | 02/07/1997 |
| K963623 | POLYMEDICA INDUSTRIES, INC. | SPYROFLEX PIGMENTED WOUND DRESSING | 10/25/1996 |
| K964398 | POLYMEDICA INDUSTRIES, INC. | SPYROFLEX PIGMENTED WOUND DRESSING/SPYROFLEX WOUND DRESSING TINTED | 10/24/1997 |
| K981713 | SMITH & NEPHEW, INC. | CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0 | 07/31/1998 |
| K992221 | WESTAIM BIOMEDICAL, INC. | ACTICOAT PRIMARY ANTIMICROBIAL DRESSING | 06/07/2000 |
| K973538 | WINFIELD LABORATORIES, INC. | N-TERFACE | 12/16/1997 |
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