COBE CENTRYSYSTEM 700 HG HEMODIALYZER

COBE CENTRYSYSTEM 700 HG HEMODIALYZER is an FDA 510(k)-cleared medical device (K962427) manufactured by Gambro 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 September 19, 1996. Regulation: 8.