The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Polysorb Ii Coated Synthetic Absorbable Suture.
| Device ID | K953869 |
| 510k Number | K953869 |
| Device Name: | POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE |
| Classification | Suture, Absorbable, Synthetic, Polyglycolic Acid |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Jonathan Gilbert |
| Correspondent | Jonathan Gilbert 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-28 |
| Decision Date | 1995-10-18 |