NXSTAGE PUREFLOW SL

Subsystem, Proportioning

NXSTAGE MEDICAL, INC.

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

Pre-market Notification Details

Device IDK080919
510k NumberK080919
Device Name:NXSTAGE PUREFLOW SL
ClassificationSubsystem, Proportioning
Applicant NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR Lawrence,  MA  01843
ContactMichael Doyle
CorrespondentMichael Doyle
NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST., 5TH FLOOR Lawrence,  MA  01843
Product CodeFKR  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2008-04-01
Decision Date2008-10-15
Summary:summary

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