510(k) K002761

FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS by Fresenius Medical Care North America — Product Code FJI

K002761 is an FDA 510(k) premarket notification submitted by Fresenius Medical Care North America for the device "FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS". The FDA issued a decision of Substantially Equivalent on December 4, 2000. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Fresenius Medical Care North America has at least 10 other 510(k) clearances on record.