The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Ussc Polyproplene Suture.
Device ID | K954808 |
510k Number | K954808 |
Device Name: | USSC POLYPROPLENE SUTURE |
Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Contact | Johnathan Gilbert |
Correspondent | Johnathan Gilbert UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Product Code | GAW |
CFR Regulation Number | 878.5010 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-10-19 |
Decision Date | 1996-02-27 |