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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 K021560
Device Name MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
Applicant
Ameriwater
1257 Stanley Ave.
Dayton,  OH  45404
Applicant Contact BRAIN R BOWMAN
Correspondent
Ameriwater
1257 Stanley Ave.
Dayton,  OH  45404
Correspondent Contact BRAIN R BOWMAN
Regulation Number876.5665
Classification Product Code
FIP  
Date Received05/13/2002
Decision Date 08/14/2003
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
Predetermined Change
Control Plan Authorized		 No
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