The following data is part of a premarket notification filed by Hospital Products Intl. with the FDA for Surgeons Choice Staple, Remove/implant.
| Device ID | K802783 |
| 510k Number | K802783 |
| Device Name: | SURGEONS CHOICE STAPLE, REMOVE/IMPLANT |
| Classification | Catheter, Pediatric, General & Plastic Surgery |
| Applicant | HOSPITAL PRODUCTS INTL. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GBN |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-11-04 |
| Decision Date | 1980-12-16 |