SELF CATH CATHETER

SELF CATH CATHETER is an FDA 510(k)-cleared medical device (K100878) 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 25, 2010. Regulation: 8.