FDA 510(k) Applications for Medical Device:
Suture, Recombinant Technology
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K100876 | AESCULAP, INC. |
3773 Corporate Parkway | Center Valley | PA | 18034 |
| K072470 | ENTRIGUE SURGICAL, INC. |
3463 MAGIC DRIVE, SUITE 320 | SAN ANTONIO | TX | 78229 |
| K211307 | Tepha, Inc. |
99 Hayden Avenue, Suite 360 | Lexington | MA | 02421 |
| DEN060003 | TEPHA, INC. |
840 MEMORIAL DRIVE | CAMBRIDGE | MA | 02139 |
| K082178 | TEPHA, INC. |
99 HAYDEN AVENUE, | LEXINGTON | MA | 02421 |
| K081099 | TEPHA, INC. |
99 HAYDEN, SUTIE 360 | LEXINGTON | MA | 02421 |
| K132348 | TEPHA, INC. |
99 HAYDEN, SUTIE 360 | LEXINGTON | MA | 02421 |
| K122487 | TORNIER, INC. |
10801 NESBITT AVENUE | BLOOMINGTON | MN | 55437 |
| K130422 | TORNIER, INC. |
10801 NESBITT AVENUE | BLOOMINGTON | MN | 55437 |
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