K911516 is an FDA 510(k) clearance for the HIGH PROFILE CHIN IMPLANT. This device is classified as a Prosthesis, Chin, Internal (Class II - Special Controls, product code FWP).
Submitted by Implantech Associates, Inc. (Washington, US). The FDA issued a Cleared decision on July 1, 1991, 88 days after receiving the submission on April 4, 1991.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3550.
| 510(k) Number | K911516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 1991 |
| Decision Date | July 01, 1991 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | FWP - Prosthesis, Chin, Internal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3550 |