K904657 is an FDA 510(k) clearance for the FLOWERS DORSAL COLUMELLA IMPLANT. This device is classified as a Prosthesis, Nose, Internal (Class II - Special Controls, product code FZE).
Submitted by Implantech Associates, Inc. (Washington, US). The FDA issued a Cleared decision on December 18, 1990, 64 days after receiving the submission on October 15, 1990.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3680.
| 510(k) Number | K904657 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 1990 |
| Decision Date | December 18, 1990 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | FZE - Prosthesis, Nose, Internal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3680 |