MODIFIED AM-SERIES DIALYZERS

MODIFIED AM-SERIES DIALYZERS is an FDA 510(k)-cleared medical device (K854575) manufactured by Asahi Medical Co., Ltd.. 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 1, 1985. Regulation: 8.