FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS

Dialyzer, High Permeability With Or Without Sealed Dialysate System

FRESENIUS USA, INC.

The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Fresenius Modified F400 Low Volume Hemoconcentrator F3000 & Modified F400 Low Vol Hemoconcentrator W/tubing Set F3000ts.

Pre-market Notification Details

Device IDK992275
510k NumberK992275
Device Name:FRESENIUS MODIFIED F400 LOW VOLUME HEMOCONCENTRATOR F3000 & MODIFIED F400 LOW VOL HEMOCONCENTRATOR W/TUBING SET F3000TS
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant FRESENIUS USA, INC. 110 MASON CR Concord,  CA 
ContactVirginia Singer
CorrespondentVirginia Singer
FRESENIUS USA, INC. 110 MASON CR Concord,  CA 
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-07
Decision Date1999-08-04
Summary:summary

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