K943988 is an FDA 510(k) clearance for the IMPLANTECH NASAL LABIAL 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 January 27, 1995, 164 days after receiving the submission on August 16, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3550.
| 510(k) Number | K943988 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 16, 1994 |
| Decision Date | January 27, 1995 |
| Days to Decision | 164 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 |