SUNMED FOLEY CATHETERS

SUNMED FOLEY CATHETERS is an FDA 510(k)-cleared medical device (K062112) manufactured by Sunmed, 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 June 3, 2007. Regulation: 8.