The following data is part of a premarket notification filed by Tyco Healthcare Group with the FDA for Polysorb* Synthetic Absorbable Suture With Modified Packaging.
Device ID | K063536 |
510k Number | K063536 |
Device Name: | POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING |
Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
Applicant | TYCO HEALTHCARE GROUP 150 GLOVER AVE. Norwalk, CT 06856 |
Contact | Robert Zott |
Correspondent | Robert Zott TYCO HEALTHCARE GROUP 150 GLOVER AVE. Norwalk, CT 06856 |
Product Code | GAM |
CFR Regulation Number | 878.4493 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-11-22 |
Decision Date | 2007-01-29 |
Summary: | summary |