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 |