The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for Micromedics S&t Total Ossicular Replacement Prosthesis And Accessories.
| Device ID | K992138 |
| 510k Number | K992138 |
| Device Name: | MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES |
| Classification | Replacement, Ossicular Prosthesis, Total |
| 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 | ETA |
| CFR Regulation Number | 874.3495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-06-24 |
| Decision Date | 1999-08-09 |