The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Absorbable Surgical Gut Suture*.
| Device ID | K885018 |
| 510k Number | K885018 |
| Device Name: | ABSORBABLE SURGICAL GUT SUTURE* |
| Classification | Suture, Absorbable, Natural |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | S Hennig |
| Correspondent | S Hennig UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | GAL |
| CFR Regulation Number | 878.4830 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-05 |
| Decision Date | 1989-08-22 |