
Pure Water Solutions, Inc.
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PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION) is an FDA 510(k)-cleared medical device (K994279) manufactured by Pure Water Solutions, 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 December 21, 2000. Regulation: 8.