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 Poly Gia Surgical Stapler.
| Device ID | K843603 |
| 510k Number | K843603 |
| Device Name: | AUTO SUTURE POLY GIA SURGICAL STAPLER |
| Classification | Staple, Implantable |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Walter S Hennig |
| Correspondent | Walter S Hennig UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-20 |
| Decision Date | 1984-10-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521047676 | K843603 | 000 |