FDA 510(k) Applications for Medical Device:
Barrier, Synthetic, Intraoral
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K965205 | AMERICAN CUSTOM MEDICAL, INC. |
2430 NORTH 7TH AVE., #4 | BOZEMAN | MT | 59715 |
| K964656 | AMERICAN CUSTOM MEDICAL, INC. |
2430 NORTH 7TH AVE., #4 | BOZEMAN | MT | 59715 |
| K982865 | ATRIX LABORATORIES, INC. |
2579 MIDPOINT DR. | FORT COLLINS | CO | 80525-4417 |
| K955838 | ATRIX LABORATORIES, INC. |
2579 MIDPOINT DR. | FORT COLLINS | CO | 80525-4417 |
| K210797 | B&Medi Co., Ltd. |
56-33, Chukhang-daero 296Beon-gil, Jung-gu | Incheon | 22339 | |
| K211554 | Cowellmedi Co., Ltd. |
48, Hakgam-daero 221beon-gil, Sasang-gu | Busan | 46986 | |
| K221851 | Criteria Industria e Comercio de Produtos Medicinais |
e Odontologicos LTDA | Sao Carlos | 13.565-261 | |
| K955646 | ETHICON, INC. |
P.O BOX 151, ROUTE 22 WEST | SOMERVILLE | NJ | 08876 |
| K960724 | GEISTLICH-PHARMA |
1050 CONNECTICUT AVE. N.W. | WASHINGTON | DC | 20036 |
| K972240 | IMTEC CORP. |
2401 NORTH COMMERCE | ARDMORE | OK | 73401 |
| K974752 | IMTEC CORP. |
2401 NORTH COMMERCE | ARDMORE | OK | 73401 |
| K033074 | INION LTD. |
LAAKARINKATU 2 | TAMPERE | 33520 | |
| K082111 | INSTITUT STRAUMANN AG |
60 MINUTEMAN ROAD | ANDOVER | MA | 01810 |
| K143327 | Neoss Ltd |
Windsor House Cornwall Road | Harrogate | Hg1 2PW | |
| K201187 | Osteogenics Biomedical, Inc. |
4620 71st St. Bldg. 78-79 | Lubbock | TX | 79424 |
| K171774 | Osteogenics Biomedical, Inc. |
4620 71st St. Bldg. 78-79 | Lubbock | TX | 79424 |
| K102184 | POREX SURGICAL, INC. |
15 DART RD. | NEWNAN | GA | 30265 |
| K091120 | POREX SURGICAL, INC. |
15 DART RD. | NEWNAN | GA | 30265 |
| K222549 | Purgo Biologics Inc. |
#812, 27 Dunchon-daero 457beon-gil, Jungwon-gu | Seongnam-si | 13219 | |
| K160493 | Salvin Dental Specialties |
3450 Latrobe Drive | Charlotte | NC | 28211 |
| K990363 | SAMYANG CORP. |
200 GREGORY LANE, SUITE C-100 | PLEASANT HILL | CA | 94523-3389 |
| K101956 | STRAUMANN USA (ON BEHALF OF INSTITUT STRAUMANN AG) |
60 MINUTEMAN ROAD | ANDOVER | MA | 01810 |
| K132325 | SUNSTAR AMERICAS, INC. |
575 8TH AVE, STE 1212 | NEW YORK | NY | 10018 |
| K151344 | Unicare Biomedical, Inc. |
23011 Moulton Parkway, J-11 | Laguna Hills | CA | 92653 |
| K051267 | W.L. GORE & ASSOCIATES, INC. |
3450 WEST KILTIE LANE, | FLAGSTAFF | AZ | |
| K960292 | W.L. GORE & ASSOCIATES,INC |
1500 NORTH FOURTH ST. | FLAGSTAFF | AZ | 86001 |
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