The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for L-25 Absorbable Surigcal Suture.
| Device ID | K013671 |
| 510k Number | K013671 |
| Device Name: | L-25 ABSORBABLE SURIGCAL 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 | 2001-11-06 |
| Decision Date | 2002-01-08 |
| Summary: | summary |