K061853 is an FDA 510(k) clearance for the GRACE MEDICAL ADJUSTABLE AND FIXED LENGTH PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESES. 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 August 18, 2006, 49 days after receiving the submission on June 30, 2006.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3450.
| 510(k) Number | K061853 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2006 |
| Decision Date | August 18, 2006 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETB - Prosthesis, Partial Ossicular Replacement |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3450 |