The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Ussc Polyproplene Suture.
| Device ID | K954808 |
| 510k Number | K954808 |
| Device Name: | USSC POLYPROPLENE SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Johnathan Gilbert |
| Correspondent | Johnathan Gilbert UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-19 |
| Decision Date | 1996-02-27 |