
Minntech Corp.
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RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330 is an FDA 510(k)-cleared medical device (K904210) manufactured by Minntech 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 November 26, 1990. Regulation: 8.