MCA 200 HEMPDIALYZER

MCA 200 HEMPDIALYZER is an FDA 510(k)-cleared medical device (K926372) 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 February 12, 1995. Regulation: 8.