FDA 510(k) Applications for Medical Device:
Gauze/Sponge, Internal
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K962972 | ACCUNEX CANADA,INC. |
100 EAST 15TH STREET, | FORT WORTH | TX | 76102 |
| K974347 | BALDUR SYSTEMS CORP. |
3423 INVESTMENT BLVD., #12 | HAYWARD | CA | 94545 |
| K990584 | BROADLINE MEDICAL INDUSTRIES |
1432 SHIRE CIRCLE | INVERNESS | IL | 60067 |
| K973299 | BROWN MEDICAL INDUSTRIES |
1300 LUNDBERG DRIVE WEST | SPIRIT LAKE | IA | 51360-7246 |
| K982648 | CELANESE ACETATE CO. |
PO BOX 32414 | CHARLOTTE | NC | 28232-2414 |
| K960615 | CERTIFIED SAFETY MFG., INC. |
1400 CHESTNUT | KANSAS CITY | MO | 64127 |
| K961061 | CODI INTERNATIONAL BV |
ONE BEACON ST. | BOSTON | MA | 02108-3190 |
| K963188 | CODI INTERNATIONAL BV |
3903 LV VEENENDAAL | TURBINESTRAAT 13-19 | ||
| K984187 | CROSSTEX INTL. |
55 NORTHERN BLVD., SUITE 410 | GREAT NECK | NY | 11021 |
| K960093 | DERIVADAS DEGASA S.A. DE C.V. |
1247 FLORIDA AVE. | PALM HARBOR | FL | 34683 |
| K961773 | DERIVADAS DEGASA S.A. DE C.V. |
40178 U.S. 19 NORTH | TARPON SPRINGS | FL | 34689 |
| K970457 | DUKAL CORP. |
40178 U.S. 19 NORTH | TARPON SPRINGS | FL | 34689 |
| K970455 | DUKAL CORP. |
40178 U.S. 19 NORTH | TARPON SPRINGS | FL | 34689 |
| K980791 | DUMEX MEDICAL SURGICAL PRODUCTS, LTD. |
104 SHORTING ROAD | TORONTO, ONTARIO | M1S 3S4 | |
| K960388 | DYNAREX CORP. |
ONE INTERNATIONAL BLVD. | BREWSTER | NY | 10509 |
| K983348 | DYNAREX CORP. |
ONE INTERNATIONAL BLVD. | BREWSTER | NY | 10509 |
| K961581 | EMERALD MEDICAL, INC. |
7-11 FACTORY LANE, SUITE 1 | MIDDLESEX | NJ | 08846 |
| K991757 | FURLONG INDUSTRIES |
311 N. SLUSSER ST. | GRAYSLAKE | IL | 60030 |
| K963724 | GRAND MEDICAL PRODUCTS |
1300 REMINGTON ROAD, SUITE K | SCHAUMBURG | IL | 60173 |
| K962234 | HOWARD MEDICAL CO. |
1690 NORTH ELSTON | CHICAGO | IL | 60622 |
| K974316 | HYDROFERA, LLC. |
322 MAIN ST., SUITE 1101 | WILLIMANTIC | CT | 06226 |
| K963134 | IGENICS, INC. |
ONE BEACON ST. | BOSTON | MA | 02108 |
| K955527 | IGENICS, INC. |
ONE BEACON ST. | BOSTON | MA | 02108 |
| K955165 | IGENICS, INC. |
ONE BEACON ST. | BOSTON | MA | 02108 |
| K973580 | INVOTEC INTERNATIONAL, INC. |
11243-1 ST. JOHNS INDUSTRIAL | JACKSONVILLE | FL | 32246 |
| K973763 | KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH |
15 HAMPSHIRE ST. | MANSFIELD | MA | 02048 |
| K960523 | NATIONAL HEALTHCARE MFG. CORP. |
251 SAULTEAUX CRESCENT | WINNIPEG, MANITOBA | R3J 3C7 | |
| K962227 | NETWORK TRADING CORP. DBA GRAND INTL. |
7222 ERTEL LN. | HOUSTON | TX | 77040 |
| K971088 | OPPORTUNITY, INC. |
1200 OLD SKOKIE RD. | HIGHLAND PARK | IL | 60035 |
| K971095 | OPPORTUNITY, INC. |
1200 OLD SKOKIE RD. | HIGHLAND PARK | IL | 60035 |
| K971075 | PRIMELINE MEDICAL PRODUCTS, INC. |
2235-27TH AVENUE, N.E. | ALBERTA | T2E 7M4 | |
| K970020 | SIMAR, INC. |
6800 LINDBERGH BLVD. | PHILADELPHIA | PA | 19142 |
| K961775 | SMITH & NEPHEW UNITED, INC. |
11775 STARKLEY RD. | LARGO | FL | 34649-1970 |
| K991215 | SYMTEX HEALTHCARE CORP. |
783 PINEFALLS AVE. | WALNUT | CA | 91789 |
| K983450 | T.C. DENTAL PRODUCTS, INC. |
20957 CURRIER RD., #E | WALNUT | CA | 91789 |
| K011941 | THE KENDALL COMPANY |
15 HAMPSHIRE ST. | MANSFIELD | MA | 02048 |
| K971178 | TRANS AIRE |
4135 NORTHGATE BLVD. SUITE 9 | SACRAMENTO | CA | 95834 |
| K983016 | VITALCARE GROUP, INC. |
15800 N.W. 13TH AVE. | MIAMI | FL | 33169 |
| K990974 | WONDER & BIOENERGY HI-TECH AMERICA, INC. |
108 N. YNEZ AVENUE, SUITE 128 | MONTEREY PARK | CA | 91754 |
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