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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 K082400
Device Name DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
Applicant
CULLIGAN SOFT WATER SERVICE CO.
6030 CULLIGAN WAY
MINNETONKA,  MN  55345
Applicant Contact MIKE JABLONSKI
Correspondent
CULLIGAN SOFT WATER SERVICE CO.
6030 CULLIGAN WAY
MINNETONKA,  MN  55345
Correspondent Contact MIKE JABLONSKI
Regulation Number876.5665
Classification Product Code
FIP  
Date Received08/20/2008
Decision Date 02/03/2009
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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