EXTRACORPOREAL'S MODEL EX-85 DIALYZER

EXTRACORPOREAL'S MODEL EX-85 DIALYZER is an FDA 510(k)-cleared medical device (K791961) 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 November 12, 1979. Regulation: 8.