IMPLANT, SILICONE AND TANTALUM

IMPLANT, SILICONE AND TANTALUM is an FDA 510(k)-cleared medical device (K760550) manufactured by Medical Instrument Research Assoc., Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 4, 1976. Regulation: 8.