HEMODIALYSIS SYSTEM AND ACCESSORY

HEMODIALYSIS SYSTEM AND ACCESSORY is an FDA 510(k)-cleared medical device (K902426) manufactured by Gainor Medical Europe, 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 November 19, 1990. Regulation: 8.