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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 K161844
Device Name Matrix Pre-Treatment Controller
Applicant
BETTER WATER, LLC.
698 SWAN DR.
SMYRNA,  TN  37167
Applicant Contact MIKE CLINE
Correspondent
BETTER WATER, LLC.
698 SWAN DR.
SMYRNA,  TN  37167
Correspondent Contact MIKE CLINE
Regulation Number876.5665
Classification Product Code
FIP  
Date Received07/05/2016
Decision Date 12/13/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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