ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS

ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS is an FDA 510(k)-cleared medical device (K962309) manufactured by Althin Medical AB an Affiliate of Baxter Intl. 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 December 26, 1996. Regulation: 8.