
Gambro, Inc.
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GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N is an FDA 510(k)-cleared medical device (K862840) 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 September 28, 1986. Regulation: 8.