
National Medical Care, Medical Products Div., Inc.
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FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER is an FDA 510(k)-cleared medical device (K952343) manufactured by National Medical Care, Medical Products Div., 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 December 21, 1995. Regulation: 8.