The following data is part of a premarket notification filed by Surgeons Choice, Inc. with the FDA for Pi-pheumo Intestinal Instrument Set.
| Device ID | K851121 |
| 510k Number | K851121 |
| Device Name: | PI-PHEUMO INTESTINAL INSTRUMENT SET |
| Classification | Stapler, Surgical |
| Applicant | SURGEONS CHOICE, INC. BAKER & MCKENZIE 815 CONNECTICUT AVENUE NW Washington, DC 20006 |
| Contact | David B Vance |
| Correspondent | David B Vance SURGEONS CHOICE, INC. BAKER & MCKENZIE 815 CONNECTICUT AVENUE NW Washington, DC 20006 |
| Product Code | GAG |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-19 |
| Decision Date | 1985-04-25 |