K963752 is an FDA 510(k) clearance for the PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS. This device is classified as a Prosthesis, Partial Ossicular Replacement (Class II - Special Controls, product code ETB).
Submitted by Grace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on October 10, 1996, 22 days after receiving the submission on September 18, 1996.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3450.
| 510(k) Number | K963752 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 1996 |
| Decision Date | October 10, 1996 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Statement |
| Product Code | ETB - Prosthesis, Partial Ossicular Replacement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3450 |