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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 K142285
Device Name AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz
Applicant
Ameriwater
1303 Stanley Ave.
Dayton,  OH  45404
Applicant Contact Brian R Bowman
Correspondent
Ameriwater
1303 Stanley Ave.
Dayton,  OH  45404
Correspondent Contact Brian R Bowman
Regulation Number876.5665
Classification Product Code
FIP  
Date Received08/18/2014
Decision Date 12/01/2014
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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