The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Caprosyn Absorbable Suture.
Device ID | K032586 |
510k Number | K032586 |
Device Name: | CAPROSYN ABSORBABLE SUTURE |
Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Contact | Robert Zott |
Correspondent | Robert Zott UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
Product Code | GAM |
CFR Regulation Number | 878.4493 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-08-22 |
Decision Date | 2003-11-17 |
Summary: | summary |