The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for Micromedics S&t Partial Ossicular Replacement Prosthesis.
| Device ID | K993234 |
| 510k Number | K993234 |
| Device Name: | MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS |
| Classification | Prosthesis, Partial Ossicular Replacement |
| Applicant | MICROMEDICS, INC. 1285 CORPORATE CENTER DR., #150 Eagan, MN 55121 |
| Contact | Charles Grote |
| Correspondent | Charles Grote MICROMEDICS, INC. 1285 CORPORATE CENTER DR., #150 Eagan, MN 55121 |
| Product Code | ETB |
| CFR Regulation Number | 874.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-27 |
| Decision Date | 1999-11-10 |