
Fresenius Medical Care Renal Therapies Group, LLC
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Hemoflow F3 and F4 Dialyzers is an FDA 510(k)-cleared medical device (K190459) manufactured by Fresenius Medical Care Renal 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 August 22, 2019. Regulation: 8.