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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tank, Holding, Dialysis
510(k) Number K141213
Device Name AMERIWATER OZONE DISINFECTION SYSTEM
Applicant
Ameriwater
1303 Stanley Ave.
Dayton,  OH  45404
Applicant Contact BRIAN BOWMAN
Correspondent
Ameriwater
1303 Stanley Ave.
Dayton,  OH  45404
Correspondent Contact BRIAN BOWMAN
Regulation Number876.5820
Classification Product Code
FIN  
Date Received05/12/2014
Decision Date 12/10/2014
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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