K913761 is an FDA 510(k) clearance for the 3-D ACCUSCAN FACIAL IMPLANTS, 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 October 17, 1991, 57 days after receiving the submission on August 21, 1991. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3550.
| 510(k) Number | K913761 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 21, 1991 |
| Decision Date | October 17, 1991 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FWP — Prosthesis, Chin, Internal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3550 |