K895152 is an FDA 510(k) clearance for the BINDER SUBMALAR FACIAL IMPLANT II. This device is classified as a Implant, Malar (Class II - Special Controls, product code LZK).
Submitted by Implantech Associates, Inc. (Washington, US). The FDA issued a Cleared decision on October 27, 1989, 78 days after receiving the submission on August 10, 1989.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3550.
| 510(k) Number | K895152 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 1989 |
| Decision Date | October 27, 1989 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | LZK - Implant, Malar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3550 |