SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS

SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS is an FDA 510(k)-cleared medical device (K950806) manufactured by Mira, 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 June 4, 1996. Regulation: 8.