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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, dialysate delivery, single patient
510(k) Number K130460
Device Name NXSTAGE DOSING CALCULATOR
Applicant
NXSTAGE MEDICAL, INC.
350 Merrimack St
LAWRENCE,  MA  01843
Applicant Contact NNAMDI NWACHUKWU
Correspondent
NXSTAGE MEDICAL, INC.
350 Merrimack St
LAWRENCE,  MA  01843
Correspondent Contact NNAMDI NWACHUKWU
Regulation Number876.5820
Classification Product Code
FKP  
Date Received02/22/2013
Decision Date 07/11/2013
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
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