K992138 is an FDA 510(k) clearance for the MICROMEDICS S&T TOTAL OSSICULAR REPLACEMENT PROSTHESIS AND ACCESSORIES. This device is classified as a Replacement, Ossicular Prosthesis, Total (Class II - Special Controls, product code ETA).
Submitted by Micromedics, Inc. (Eagan, US). The FDA issued a Cleared decision on August 9, 1999, 46 days after receiving the submission on June 24, 1999.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3495.
| 510(k) Number | K992138 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 1999 |
| Decision Date | August 09, 1999 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | ETA — Replacement, Ossicular Prosthesis, Total |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3495 |