GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R

GAMBRO POLYFLUX 24S, GAMBRO POLYFLUX 24R is an FDA 510(k)-cleared medical device (K010667) 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 June 3, 2001. Regulation: 8.