510(k) K982134

DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851 by Dynamic Technology Corp. — Product Code KDI

K982134 is an FDA 510(k) premarket notification submitted by Dynamic Technology Corp. for the device "DYNAMIC HOLLOW FIBER DIALYZER DS-SERIES MODEL AS-851". The FDA issued a decision of Substantially Equivalent on April 14, 1999. 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.