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(r) Surgiport Dispos Surg Trocar/sleeve.
| Device ID | K874879 |
| 510k Number | K874879 |
| Device Name: | AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVE |
| Classification | Gouge, Surgical, General & Plastic Surgery |
| Applicant | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Contact | Curtis Raymond |
| Correspondent | Curtis Raymond UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC 150 GLOVER AVE. Norwalk, CT 06856 |
| Product Code | GDH |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-09 |
| Decision Date | 1987-12-17 |