
Isopure, Corp.
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Isopure Dry Acid Dissolution System is an FDA 510(k)-cleared medical device (K191093) 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 21, 2020. Regulation: 8.