K972815 is an FDA 510(k) clearance for the PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT. 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 October 8, 1997, 72 days after receiving the submission on July 28, 1997.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3450.
| 510(k) Number | K972815 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 1997 |
| Decision Date | October 08, 1997 |
| Days to Decision | 72 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 |