GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER

GAMBRO LUNDIA PLATE HIGH FLUX DIALYZER is an FDA 510(k)-cleared medical device (K811944) manufactured by Gambro, 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 August 30, 1981. Regulation: 8.