KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER

KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER is an FDA 510(k)-cleared medical device (K931459) manufactured by Kendall Healthcare Products Co. Div.Of Tyco Health. 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 June 13, 1993. Regulation: 8.