
Fresenius Medical Care North America
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Optiflux dialyzer is an FDA 510(k)-cleared medical device (K152367) manufactured by Fresenius Medical Care North America. 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 October 28, 2015. Regulation: 8.