GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR

GAMBRO POLYFLUX 6 LR, 8 LR AND 10 LR is an FDA 510(k)-cleared medical device (K023615) 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 May 5, 2003. Regulation: 8.