TRIEX-IH DIALYZER

TRIEX-IH DIALYZER is an FDA 510(k)-cleared medical device (K822738) manufactured by Extracorporeal Medical Specialities, 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 September 23, 1982. Regulation: 8.