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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
1303 Stanley Avenue
dayton,  OH  45404
Applicant Contact brian r bowman
1303 Stanley Avenue
dayton,  OH  45404
Correspondent Contact brian r bowman
Regulation Number876.5665
Classification Product Code
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