
Minntech Corp.
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PRIMUS HOLLOW FIBER DIALYZER MOD. 1000, 1350, 2000 is an FDA 510(k)-cleared medical device (K923727) 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 July 28, 1994. Regulation: 8.