ASAHI AM-R SERIES DIALYZERS

ASAHI AM-R SERIES DIALYZERS is an FDA 510(k)-cleared medical device (K970650) 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 September 29, 1997. Regulation: 8.