The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Auto Suture*endostitch* Ii** Suture Applier.
| Device ID | K972911 |
| 510k Number | K972911 |
| Device Name: | AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Victor Clavelli |
| Correspondent | Victor Clavelli UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-07 |
| Decision Date | 1998-04-25 |
| Summary: | summary |