K961210 is an FDA 510(k) clearance for the SAM FACIAL IMPLANT. This device is classified as a Implant, Malar (Class II - Special Controls, product code LZK).
Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on June 19, 1996, 83 days after receiving the submission on March 28, 1996.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3550.
| 510(k) Number | K961210 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 1996 |
| Decision Date | June 19, 1996 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LZK — Implant, Malar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3550 |