K022511 is an FDA 510(k) clearance for the AART CALF IMPLANT. This device is classified as a Elastomer, Silicone Block (Class II - Special Controls, product code MIB).
Submitted by Aesthetic and Reconstructive Technologies, Inc. (Paso Robles, US). The FDA issued a Cleared decision on August 26, 2002, 27 days after receiving the submission on July 30, 2002.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 874.3620.
| 510(k) Number | K022511 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 30, 2002 |
| Decision Date | August 26, 2002 |
| Days to Decision | 27 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | MIB — Elastomer, Silicone Block |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.3620 |