GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS

GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS is an FDA 510(k)-cleared medical device (K041005) manufactured by Gambro Renal Products. 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 October 6, 2004. Regulation: 8.