
Gambro Renal Products, Inc.
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MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT is an FDA 510(k)-cleared medical device (K133807) manufactured by Gambro Renal Products, 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 March 25, 2014. Regulation: 8.