The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Sofsilk Suture.
| Device ID | K980124 |
| 510k Number | K980124 |
| Device Name: | SOFSILK SUTURE |
| Classification | Suture, Nonabsorbable, Silk |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Christopher A Graham |
| Correspondent | Christopher A Graham UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | GAP |
| CFR Regulation Number | 878.5030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-14 |
| Decision Date | 1998-03-27 |
| Summary: | summary |