DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR

DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR is an FDA 510(k)-cleared medical device (K071049) manufactured by Tyco Healthcare. 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 October 15, 2007. Regulation: 8.