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 |