NXSTAGE SYSTEM ONE

Dialyzer, High Permeability With Or Without Sealed Dialysate System

NXSTAGE MEDICAL, INC.

The following data is part of a premarket notification filed by Nxstage Medical, Inc. with the FDA for Nxstage System One.

Pre-market Notification Details

Device IDK041424
510k NumberK041424
Device Name:NXSTAGE SYSTEM ONE
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
Applicant NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR Lawrence,  MA  01843
ContactNorma Lemay
CorrespondentNorma Lemay
NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR Lawrence,  MA  01843
Product CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-05-28
Decision Date2004-07-02
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.