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FDA 510(k) Applications for Medical Device:
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| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K971988 | ALLEN MEDICAL SYSTEMS, INC. |
15627 NEO PKWY. | CLEVELAND | OH | 44128 |
| K961742 | ALM SURGICAL EQUIPMENT, INC. |
1820 NORTH LEMON ST. | ANAHEIM | CA | 92801-1009 |
| K961886 | ALM SURGICAL EQUIPMENT, INC. |
1820 NORTH LEMON ST. | ANAHEIM | CA | 92801-1009 |
| K955750 | BERCHTOLD HOLDING GMBH |
LUDWIGSTALER STR. 25 | TUTTLINGEN | D-78532 | |
| K221410 | Moon Surgical |
c/o Sofinnova Partners, 7/11 Bd Haussmann | Paris | 75009 | |
| K240598 | Moon Surgical |
9 rue dÆEnghien | Paris | 75010 | |
| K972810 | O.P.T. USA, INC. |
235 SACKETT ST. | BROOKLYN | NY | 11231 |
| K971307 | STERIS Corporation |
5960 HEISLEY RD. | MENTOR | OH | 44060 |
| K090136 | STERIS Corporation |
5960 Heisley Road | Mentor | OH | 44060 |
| K963506 | TENET MEDICAL ENGINEERING |
3553 31ST ST., N.W. | CALGARY | T2L 2K7 |