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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 K002045
Device Name WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
Applicant
Total Water Treatment Systems, Inc.
4806 E. Broadway
Madison,  WI  53716
Applicant Contact KENNETH J CLARK
Correspondent
Total Water Treatment Systems, Inc.
4806 E. Broadway
Madison,  WI  53716
Correspondent Contact KENNETH J CLARK
Regulation Number876.5665
Classification Product Code
FIP  
Date Received07/05/2000
Decision Date 02/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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