About This 510(k) Submission
K982414 is an FDA 510(k) clearance for the GAMBRO POLYFLUX 11S, 14S, 17S & 21S HEMODIALYZERS/ HEMOFILTERS, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Gambro Healthcare (Lakewood, US). The FDA issued a Cleared decision on March 26, 1999, 256 days after receiving the submission on July 13, 1998. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.