About This 510(k) Submission
K043342 is an FDA 510(k) clearance for the POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR, a Dialyzer, Capillary, Hollow Fiber (Class II — Special Controls, product code FJI), submitted by Gambro Renal Products (Lakewood, US). The FDA issued a Cleared decision on May 27, 2005, 172 days after receiving the submission on December 6, 2004. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.