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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name dialysate concentrate for hemodialysis (liquid or powder)
510(k) Number K042045
Device Name NXSTAGE PUREFLOW-B SOLUTION
Applicant
NXSTAGE MEDICAL, INC.
439 SOUTH UNION ST.,STE 501
LAWRENCE,  MA  01843
Applicant Contact NORMA LEMAY
Correspondent
NXSTAGE MEDICAL, INC.
439 SOUTH UNION ST.,STE 501
LAWRENCE,  MA  01843
Correspondent Contact NORMA LEMAY
Regulation Number876.5820
Classification Product Code
KPO  
Date Received07/30/2004
Decision Date 08/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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