K991394 is an FDA 510(k) clearance for the STAPES PROSTHESES. This device is classified as a Prosthesis, Partial Ossicular Replacement (Class II - Special Controls, product code ETB).
Submitted by Grace Medical, Inc. (Bartlett, US). The FDA issued a Cleared decision on May 18, 1999, 27 days after receiving the submission on April 21, 1999.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3450.
| 510(k) Number | K991394 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 21, 1999 |
| Decision Date | May 18, 1999 |
| Days to Decision | 27 days |
| Submission Type | Special |
| 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 |