FDA 510(k) Applications for Medical Device Product Code "EFQ"
(Gauze/Sponge, Internal)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K962972 | ACCUNEX CANADA,INC. | SURGICADE GAUZE SPONGE | 10/11/1996 |
| K974347 | BALDUR SYSTEMS CORP. | BALDUR NON-STERILE COTTON SPONGES | 02/10/1998 |
| K990584 | BROADLINE MEDICAL INDUSTRIES | GAUZE SPONGES: LAPAROTOMY SPONGE, X-RAY DETECTABLE | 04/23/1999 |
| K973299 | BROWN MEDICAL INDUSTRIES | PIN CARE KIT | 11/26/1997 |
| K982648 | CELANESE ACETATE CO. | JOAN II | 09/30/1998 |
| K960615 | CERTIFIED SAFETY MFG., INC. | GAUZE COMPRESS | 11/25/1996 |
| K961061 | CODI INTERNATIONAL BV | CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE) | 06/06/1996 |
| K963188 | CODI INTERNATIONAL BV | DRAIN/SLIT SPONGE (NON-STERILE AND STERILE) | 10/30/1996 |
| K984187 | CROSSTEX INTL. | CROSSTEX NON-WOVEN SPONGES | 02/18/1999 |
| K960093 | DERIVADAS DEGASA S.A. DE C.V. | PROTEC ROLL GAUZE | 03/25/1996 |
| K961773 | DERIVADAS DEGASA S.A. DE C.V. | PROTEC STERILE GAUZE SPONGE | 07/29/1996 |
| K970457 | DUKAL CORP. | DUKAL ABD COMBINE PAD | 05/08/1997 |
| K970455 | DUKAL CORP. | DUKAL NON ADHERENT DRESSING | 05/08/1997 |
| K980791 | DUMEX MEDICAL SURGICAL PRODUCTS, LTD. | DUMEX PAK-ITS WOVEN RIBBON PACKING | 04/29/1998 |
| K960388 | DYNAREX CORP. | DYNAREX NON-WOVEN SPONGE | 04/01/1996 |
| K983348 | DYNAREX CORP. | DYNAREX TRACHEOSTOMY SPONGE | 12/11/1998 |
| K961581 | EMERALD MEDICAL, INC. | EMERALD STERILE GAUZE SPONGE | 05/28/1996 |
| K991757 | FURLONG INDUSTRIES | NON-ABSORBABLE GAUZE FOR EXTERNAL USE, STERILE AND NON STERILE | 08/12/1999 |
| K963724 | GRAND MEDICAL PRODUCTS | GAUZE SPONGE, NON X-RAY DETECTABLE | 11/29/1996 |
| K962234 | HOWARD MEDICAL CO. | STERILE GAUZE SPONGE - PICK-UPS 12PLY (GS-412), PICK-UPS 16PLY (GS-416) | 06/28/1996 |
| K974316 | HYDROFERA, LLC. | HYDROFERA FEMORAL WICK | 02/13/1998 |
| K963134 | IGENICS, INC. | DRAIN/SLIT SPONGE (NON-STERILE AND STERILE) | 09/06/1996 |
| K955527 | IGENICS, INC. | GENERAL USE SYNTHETIC SPONGE (STERILE) | 02/05/1996 |
| K955165 | IGENICS, INC. | SYNTHETIC SPONGE | 02/05/1996 |
| K973580 | INVOTEC INTERNATIONAL, INC. | INVOTEC CLEAN PAD | 12/10/1997 |
| K973763 | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH | KENDALL CURITY IODOFORM PACKING STRIP | 12/31/1997 |
| K960523 | NATIONAL HEALTHCARE MFG. CORP. | NHMC DRESSING TRAY | 04/04/1996 |
| K962227 | NETWORK TRADING CORP. DBA GRAND INTL. | PRO-FECT STERILE GAUZE SPONGES | 08/19/1996 |
| K971088 | OPPORTUNITY, INC. | OPPORTUNITY INCISION AND DRAINAGE TRAY | 09/16/1997 |
| K971095 | OPPORTUNITY, INC. | OPPORTUNITY SUTURE REMOVAL KIT | 09/16/1997 |
| K971075 | PRIMELINE MEDICAL PRODUCTS, INC. | PRIMED PRIME-PLUS COTTON GAUZE SPONGES | 06/22/1997 |
| K970020 | SIMAR, INC. | SIMAR, INC. SURGICAL DRESSING | 03/20/1997 |
| K961775 | SMITH & NEPHEW UNITED, INC. | PROFORE FOUR-LAYER BANDAGE SYSTEM KIT | 07/16/1996 |
| K991215 | SYMTEX HEALTHCARE CORP. | SYMTEX GAUZE PADS (1'S) AND SYMTEX GAUZE SPONGES STERILE 2'S AND STERILE 10'S | 06/11/1999 |
| K983450 | T.C. DENTAL PRODUCTS, INC. | STARRYSHINE GAUZE SPONGE | 11/12/1998 |
| K011941 | THE KENDALL COMPANY | EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088 | 08/22/2001 |
| K971178 | TRANS AIRE | RAND SURGICAL SPONGE | 06/27/1997 |
| K983016 | VITALCARE GROUP, INC. | GAUZE, SPONGES, CAT # 11-003 | 02/12/1999 |
| K990974 | WONDER & BIOENERGY HI-TECH AMERICA, INC. | VITOP DRESSING | 06/09/1999 |
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