WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS

WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS is an FDA 510(k)-cleared medical device (K083712) manufactured by Dipure, LLC. 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 July 9, 2009. Regulation: 8.