GAMBRO CARTRIDGE BLOOD SETS

GAMBRO CARTRIDGE BLOOD SETS is an FDA 510(k)-cleared medical device (K070414) manufactured by Gambro Renal Products. 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 11, 2007. Regulation: 8.