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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, sealed
510(k) Number K030470
Device Name NXSTAGE SYSTEM ONE
Applicant
NXSTAGE MEDICAL, INC.
439 SOUTH UNION ST.
SUITE 501
LAWRENCE,  MA  01843
Applicant Contact NORMA LEMAY
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact DONALD J SHERRATT
Regulation Number876.5860
Classification Product Code
FII  
Date Received02/12/2003
Decision Date 07/07/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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