K002886 is an FDA 510(k) clearance for the IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL). This device is classified as a Implant, Malar (Class II - Special Controls, product code LZK).
Submitted by Implantech Associates, Inc. (Ventura, US). The FDA issued a Cleared decision on November 24, 2000, 70 days after receiving the submission on September 15, 2000.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3550.
| 510(k) Number | K002886 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 15, 2000 |
| Decision Date | November 24, 2000 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | LZK - Implant, Malar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3550 |