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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 K992793
Device Name SODIUM BICARBONATE MIXING/DELIVERY SYSTEM, AND THE CONCENTRATE DELIVERY SYSTEM
Applicant
Better Water, Inc.
698 Swan Dr.
Smyrna,  TN  37167
Applicant Contact MIKE S STERLING
Correspondent
Better Water, Inc.
698 Swan Dr.
Smyrna,  TN  37167
Correspondent Contact MIKE S STERLING
Regulation Number876.5820
Classification Product Code
FIN  
Date Received08/19/1999
Decision Date 11/16/1999
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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