NXSTAGE DIALYSATE PREPARATION MODULE

Subsystem, Proportioning

NXSTAGE MEDICAL, INC.

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

Pre-market Notification Details

Device IDK060296
510k NumberK060296
Device Name:NXSTAGE DIALYSATE PREPARATION MODULE
ClassificationSubsystem, Proportioning
Applicant NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST. SUITE 501 Lawrence,  MA  01843
ContactNorma Lemay
CorrespondentNorma Lemay
NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST. SUITE 501 Lawrence,  MA  01843
Product CodeFKR  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-02-06
Decision Date2006-03-31
Summary:summary

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