HYDROSIL; MAGIC; PERSONAL CATHETER

HYDROSIL; MAGIC; PERSONAL CATHETER is an FDA 510(k)-cleared medical device (K122785) 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 May 13, 2013. Regulation: 8.