The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for The Surgical Dynamics* S.d. Sorb* E-z Tac*.
| Device ID | K973281 |
| 510k Number | K973281 |
| Device Name: | THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC* |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Sharon L Murphy |
| Correspondent | Sharon L Murphy UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-02 |
| Decision Date | 1997-11-03 |
| Summary: | summary |