PRISMAFLEX M150 SET

PRISMAFLEX M150 SET is an FDA 510(k)-cleared medical device (K080519) 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 June 12, 2008. Regulation: 8.