The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Fine Size Nonabsorbable Dacron Surgical Suture.
| Device ID | K905440 |
| 510k Number | K905440 |
| Device Name: | FINE SIZE NONABSORBABLE DACRON SURGICAL SUTURE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyester |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Steve Reitzler |
| Correspondent | Steve Reitzler UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | GAS |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-04 |
| Decision Date | 1991-01-31 |