510(k) K974584

FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS by Fresenius USA, Inc. — Product Code KDI

K974584 is an FDA 510(k) premarket notification submitted by Fresenius USA, Inc. for the device "FRESENIUS F SERIES HEMOCONCENTRATORS F400,F500,F700,F800,F400TS,F500TS,F700S,F800TS". The FDA issued a decision of Substantially Equivalent on May 14, 1998. The device falls under product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System), a Class II device regulated under 21 CFR 876.5860. Fresenius USA, Inc. has at least 10 other 510(k) clearances on record.