DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS

DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS is an FDA 510(k)-cleared medical device (K082400) manufactured by Culligan Soft Water Service Co.. 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 February 2, 2009. Regulation: 8.