K964443 is an FDA 510(k) clearance for the SURGIFORM ANATOMICAL MALAR, a Implant, Malar (Class II — Special Controls, product code LZK), submitted by Surgical Technology Laboratories, Inc. (Cleveland, US). The FDA issued a Cleared decision on December 20, 1996, 44 days after receiving the submission on November 6, 1996. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3550.
| 510(k) Number | K964443 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 06, 1996 |
| Decision Date | December 20, 1996 |
| Days to Decision | 44 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 |