The following data is part of a premarket notification filed by United States Surgical, A Division Of Tyco Healthc with the FDA for Surgical Staple.
| Device ID | K942606 |
| 510k Number | K942606 |
| Device Name: | SURGICAL STAPLE |
| Classification | Staple, Implantable |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Deborah Rockafellow |
| Correspondent | Deborah Rockafellow 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 | 1994-06-01 |
| Decision Date | 1994-08-24 |