SILASTIC BRAND PENILE IMPLANT

SILASTIC BRAND PENILE IMPLANT is an FDA 510(k)-cleared medical device (K780484) manufactured by Dow Corning Corp. Healthcare Industries Materials. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 16, 1978. Regulation: 8.