K961080 is an FDA 510(k) clearance for the MEDIAL MALAR IMPLANT. This device is classified as a Implant, Malar (Class II - Special Controls, product code LZK).
Submitted by Rand Scientific Corp. (Sacramento, US). The FDA issued a Cleared decision on April 19, 1996, 32 days after receiving the submission on March 18, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3550.
| 510(k) Number | K961080 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 1996 |
| Decision Date | April 19, 1996 |
| Days to Decision | 32 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 |