RENALFO HEMOFILTER CAVHD

Dialyzer, High Permeability With Or Without Sealed Dialysate System

RENAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Renal Systems, Inc. with the FDA for Renalfo Hemofilter Cavhd.

Pre-market Notification Details

Device IDK854011
510k NumberK854011
Device Name:RENALFO HEMOFILTER CAVHD
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant RENAL SYSTEMS, INC. 14905 28TH AVE. N. Minneapolis,  MN  55441
ContactLeroy Fischbach
CorrespondentLeroy Fischbach
RENAL SYSTEMS, INC. 14905 28TH AVE. N. Minneapolis,  MN  55441
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-09-30
Decision Date1985-11-05

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