RENAFLO HEMOCONCENTRATOR

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 Renaflo Hemoconcentrator.

Pre-market Notification Details

Device IDK844790
510k NumberK844790
Device Name:RENAFLO HEMOCONCENTRATOR
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant RENAL SYSTEMS, INC. 14905 28TH AVE. N. Minneapolis,  MN  55441
ContactLeroy J Fischbach
CorrespondentLeroy J 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 Received1984-12-10
Decision Date1985-05-23

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