SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM

SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEM is an FDA 510(k)-cleared medical device (K070939) manufactured by Coloplast Manufacturing Us, LLC. 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 31, 2007. Regulation: 8.