STERILE, ALL PURPOSE URETHRAL CATHETER

STERILE, ALL PURPOSE URETHRAL CATHETER is an FDA 510(k)-cleared medical device (K830444) manufactured by Abco Dealers, Inc.. 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 8, 1983. Regulation: 8.