K871074 is an FDA 510(k) clearance for the OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR. This device is classified as a Prosthesis, Chin, Internal (Class II - Special Controls, product code FWP).
Submitted by Omega Silicone, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on April 10, 1987, 23 days after receiving the submission on March 18, 1987.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3550.
| 510(k) Number | K871074 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 1987 |
| Decision Date | April 10, 1987 |
| Days to Decision | 23 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 |