NXSTAGE PREMIXED DIALYSATE

Dialysate Concentrate For Hemodialysis (liquid Or Powder)

NXSTAGE MEDICAL, INC.

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

Pre-market Notification Details

Device IDK022913
510k NumberK022913
Device Name:NXSTAGE PREMIXED DIALYSATE
ClassificationDialysate Concentrate For Hemodialysis (liquid Or Powder)
Applicant NXSTAGE MEDICAL, INC. 439 SOUTH UNION ST. SUITE 501 Lawrence,  MA  01843
ContactNorma Lemay
CorrespondentDonald James Sherratt
INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg,  OH  44087
Product CodeKPO  
CFR Regulation Number876.5820 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2002-09-03
Decision Date2002-10-21
Summary:summary

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