
Isopure, Corp.
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MD 420/440/460/470/480/490 is an FDA 510(k)-cleared medical device (K993200) manufactured by Isopure, Corp.. 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 January 23, 2000. Regulation: 8.