MENTOR SELF-CATH CLOSED SYSTEM

MENTOR SELF-CATH CLOSED SYSTEM is an FDA 510(k)-cleared medical device (K003873) manufactured by Mentor 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 March 28, 2001. Regulation: 8.