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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Subsystem, Proportioning
510(k) Number K043436
Device Name NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269
Applicant
NXSTAGE MEDICAL, INC.
439 SOUTH UNION ST.
SUITE 501
LAWRENCE,  MA  01843
Applicant Contact NORMA LEMAY
Correspondent
NXSTAGE MEDICAL, INC.
439 SOUTH UNION ST.
SUITE 501
LAWRENCE,  MA  01843
Correspondent Contact NORMA LEMAY
Regulation Number876.5820
Classification Product Code
FKR  
Subsequent Product Code
KPO  
Date Received12/13/2004
Decision Date 03/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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