510(k) K980386

HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0) by Gambro Healthcare — Product Code KDI

K980386 is an FDA 510(k) premarket notification submitted by Gambro Healthcare for the device "HOSPAL MULTIFLOW 100, MULTIFLOW 100 KITS A0 (A0,A0/B AND A0/0), MULTIFLOW 100 KITS B22 (B22,B22/B, & B22/0)". The FDA issued a decision of Substantially Equivalent on February 24, 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. Gambro Healthcare has at least 10 other 510(k) clearances on record.