The following data is part of a premarket notification filed by American Heyer Schulte with the FDA for Amer. V. Mueller Surg. Staples Ila.
| Device ID | K833698 |
| 510k Number | K833698 |
| Device Name: | AMER. V. MUELLER SURG. STAPLES ILA |
| Classification | Staple, Implantable |
| Applicant | AMERICAN HEYER SCHULTE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-15 |
| Decision Date | 1984-01-25 |