MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS

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 Modification To Nxstage Cartridge Express.

Pre-market Notification Details

Device IDK050727
510k NumberK050727
Device Name:MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS
ClassificationDialyzer, High Permeability With Or Without Sealed Dialysate System
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 CodeKDI  
CFR Regulation Number876.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-21
Decision Date2005-06-13
Summary:summary

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