
Fresenius USA, Inc.
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FRESENIUS F8 DIALYZER is an FDA 510(k)-cleared medical device (K883195) manufactured by Fresenius USA, Inc.. 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 September 12, 1988. Regulation: 8.