The following data is part of a premarket notification filed by Humboldt Products with the FDA for Drumto Stapes Prosthesis.
| Device ID | K832540 |
| 510k Number | K832540 |
| Device Name: | DRUMTO STAPES PROSTHESIS |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | HUMBOLDT PRODUCTS 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-29 |
| Decision Date | 1984-01-03 |