The following data is part of a premarket notification filed by Surgeons Choice, Inc. with the FDA for Surgeons Choice Pi Vascular Stapling.
| Device ID | K843399 |
| 510k Number | K843399 |
| Device Name: | SURGEONS CHOICE PI VASCULAR STAPLING |
| Classification | Staple, Implantable |
| Applicant | SURGEONS CHOICE, INC. 815 CONNECTICUT AVENUE NW Washington , DC 20006 - |
| Contact | David B Vance |
| Correspondent | David B Vance SURGEONS CHOICE, INC. 815 CONNECTICUT AVENUE NW Washington , DC 20006 - |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-30 |
| Decision Date | 1984-11-05 |