K941960 is an FDA 510(k) clearance for the IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II. 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 August 17, 1994, 117 days after receiving the submission on April 22, 1994.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3680.
| 510(k) Number | K941960 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 22, 1994 |
| Decision Date | August 17, 1994 |
| Days to Decision | 117 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FZE - Prosthesis, Nose, Internal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3680 |