The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Nonabsorbable Nylon Surgical Suture*.
Device ID | K900531 |
510k Number | K900531 |
Device Name: | NONABSORBABLE NYLON SURGICAL SUTURE* |
Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
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 | GAR |
CFR Regulation Number | 878.5020 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-05 |
Decision Date | 1990-07-05 |