AART GLUTEAL IMPLANT

AART GLUTEAL IMPLANT is an FDA 510(k)-cleared medical device (K021839) manufactured by Aesthetic and Reconstructive Technologies, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 15, 2002. Regulation: 8.