POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR

POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR is an FDA 510(k)-cleared medical device (K043342) 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 May 26, 2005. Regulation: 8.