AART SILICONE SHEETING

AART SILICONE SHEETING is an FDA 510(k)-cleared medical device (K022223) 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 August 7, 2002. Regulation: 8.