The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Nonabsorbable Dacron Surgical Suture*.
Device ID | K902873 |
510k Number | K902873 |
Device Name: | 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 For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-29 |
Decision Date | 1990-09-27 |