TORAYSULFONE DIALYZER

TORAYSULFONE DIALYZER is an FDA 510(k)-cleared medical device (K002512) manufactured by Toray Industries (America), Inc.. 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 October 14, 2001. Regulation: 8.