
Serv-A-Pure Co.
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H20NLY COMPLETE WATER PURIFICATION SYSTEM FOR HEMODIALYSIS is an FDA 510(k)-cleared medical device (K993520) manufactured by Serv-A-Pure 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 May 2, 2000. Regulation: 8.