
Gambro Healthcare
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COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS is an FDA 510(k)-cleared medical device (K982413) manufactured by Gambro Healthcare. 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 April 20, 1999. Regulation: 8.