510(k) K050952

HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR by Minntech Corp. — Product Code KDI

K050952 is an FDA 510(k) premarket notification submitted by Minntech Corp. for the device "HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR". The FDA issued a decision of Substantially Equivalent on January 31, 2006. 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. Minntech Corp. has at least 10 other 510(k) clearances on record.