K980139 is an FDA 510(k) clearance for the SPECTRUM DESIGNS PROFILE MALAR IMPLANT, a Implant, Malar (Class II — Special Controls, product code LZK), submitted by Spectrum Designs, Inc. (Goleta, US). The FDA issued a Cleared decision on March 3, 1998, 47 days after receiving the submission on January 15, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3550.
| 510(k) Number | K980139 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 15, 1998 |
| Decision Date | March 03, 1998 |
| Days to Decision | 47 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 |