
Gambro, Inc.
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GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS is an FDA 510(k)-cleared medical device (K896757) manufactured by Gambro, 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 August 29, 1990. Regulation: 8.