BINDER SUBMALAR FACIAL IMPLANT

BINDER SUBMALAR FACIAL IMPLANT is an FDA 510(k)-cleared medical device (K894493) manufactured by Implantech Associates, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 26, 1989. Regulation: 8.