SILICONE-SILVER PENILE PROSTHESIS-ESK

SILICONE-SILVER PENILE PROSTHESIS-ESK is an FDA 510(k)-cleared medical device (K830667) manufactured by Dacomed Corp.. 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 October 19, 1983. Regulation: 8.