The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Fasterner, Fixation, Biodegradable Soft Tissue.
| Device ID | K965228 |
| 510k Number | K965228 |
| Device Name: | FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Melissa Mazzoni |
| Correspondent | Melissa Mazzoni 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 | 1996-12-31 |
| Decision Date | 1997-11-10 |
| Summary: | summary |