510(k) K011537

DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS by Dynamic Technology Corp. — Product Code KDI

K011537 is an FDA 510(k) premarket notification submitted by Dynamic Technology Corp. for the device "DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES, MODEL: POLYSULFONE 100 HFS, POLYSULFONE 130 HFS". The FDA issued a decision of Substantially Equivalent on January 7, 2002. 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. Dynamic Technology Corp. has at least 3 other 510(k) clearances on record.