K091187 is an FDA 510(k) clearance for the GRACE DYNAMIC TORP. This device is classified as a Replacement, Ossicular Prosthesis, Total (Class II - Special Controls, product code ETA).
Submitted by Grace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on September 14, 2009, 144 days after receiving the submission on April 23, 2009.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3495.
| 510(k) Number | K091187 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2009 |
| Decision Date | September 14, 2009 |
| Days to Decision | 144 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | ETA - Replacement, Ossicular Prosthesis, Total |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3495 |