ALL SILICONE FOLEY CATHETER

ALL SILICONE FOLEY CATHETER is an FDA 510(k)-cleared medical device (K896053) manufactured by Rochester Medical 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 February 11, 1990. Regulation: 8.