K973502 is an FDA 510(k) clearance for the IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT, a Implant, Malar (Class II — Special Controls, product code LZK), submitted by Implantech Associates, Inc. (Washington, US). The FDA issued a Cleared decision on November 7, 1997, 52 days after receiving the submission on September 16, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3550.
| 510(k) Number | K973502 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 16, 1997 |
| Decision Date | November 07, 1997 |
| Days to Decision | 52 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 |