About This 510(k) Submission
K974584 is an FDA 510(k) clearance for the FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS, a Dialyzer, High Permeability With Or Without Sealed Dialysate System (Class II — Special Controls, product code KDI), submitted by Fresenius USA, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on May 14, 1998, 157 days after receiving the submission on December 8, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5860.