K021419 is an FDA 510(k) clearance for the AART MALAR IMPLANT. This device is classified as a Implant, Malar (Class II - Special Controls, product code LZK).
Submitted by Aesthetic and Reconstructive Technologies, Inc. (Reno, US). The FDA issued a Cleared decision on July 2, 2002, 60 days after receiving the submission on May 3, 2002.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3550.
| 510(k) Number | K021419 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2002 |
| Decision Date | July 02, 2002 |
| Days to Decision | 60 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 |