K943988 is an FDA 510(k) clearance for the IMPLANTECH NASAL LABIAL IMPLANT. This device is classified as 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 FDA review panel. Regulated under 21 CFR 878.3550.
| 510(k) Number | K943988 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |