
Millipore Corp.
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MILLEX, DUALEX (PLUS, ULTRA) is an FDA 510(k)-cleared medical device (K934069) manufactured by Millipore 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 April 20, 1994. Regulation: 8.