SILICONE ELASTOMER MALAR IMPLANT

SILICONE ELASTOMER MALAR IMPLANT is an FDA 510(k)-cleared medical device (K952707) manufactured by Spirit Ridge Technologies. 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 August 27, 1995. Regulation: 8.