
Althin Medical AB an Affiliate of Baxter Intl
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ALTRA NOVA 200 HEMODIALYZER is an FDA 510(k)-cleared medical device (K970681) manufactured by Althin Medical AB an Affiliate of Baxter Intl. 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 22, 1998. Regulation: 8.