The following data is part of a premarket notification filed by American Heyer Schulte with the FDA for Amer. V. Mueller Surgicalstaples-cartr.
| Device ID | K833704 |
| 510k Number | K833704 |
| Device Name: | AMER. V. MUELLER SURGICALSTAPLES-CARTR |
| Classification | Staple, Implantable |
| Applicant | AMERICAN HEYER SCHULTE 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-18 |
| Decision Date | 1983-12-29 |