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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name subsystem, water purification
510(k) Number K042089
Device Name NX STAGE WATER PURIFICATION SYSTEM
Applicant
NX STAGE MEDICAL INC
439 SOUTH UNION ST. STE 501
LAWRENCE,  MA  01843
Applicant Contact NORMA LEMAY
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
UNIT B7
TWINSBURG,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number876.5665
Classification Product Code
FIP  
Date Received08/03/2004
Decision Date 11/24/2004
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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