510(k) K122952

NIPRO PUREFLUX-L HEMODIALYZER by Nipro Medical Corporation — Product Code FJI

K122952 is an FDA 510(k) premarket notification submitted by Nipro Medical Corporation for the device "NIPRO PUREFLUX-L HEMODIALYZER". The FDA issued a decision of Substantially Equivalent on December 4, 2013. The device falls under product code FJI (Dialyzer, Capillary, Hollow Fiber), a Class II device regulated under 21 CFR 876.5820. Nipro Medical Corporation has at least 10 other 510(k) clearances on record.