
Fresenius Medical Care Reanal Therapies Group, LLC
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Optiflux Enexa F500 Dialyzer is an FDA 510(k)-cleared medical device (K192928) manufactured by Fresenius Medical Care Reanal Therapies Group, LLC. 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 8, 2020. Regulation: 8.