The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Polysorb Synthetic Absorbable Suture.
| Device ID | K895579 |
| 510k Number | K895579 |
| Device Name: | POLYSORB SYNTHETIC ABSORBABLE SUTURE |
| Classification | Suture, Absorbable, Synthetic |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Walter S Hennig |
| Correspondent | Walter S Hennig UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | GAN |
| CFR Regulation Number | 878.4830 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-15 |
| Decision Date | 1990-07-05 |