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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 K051620
Device Name MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES
Applicant
BETTER WATER, INC.
698 SWAN DR.
SMYRNA,  TN  37167
Applicant Contact MICHAEL CLINE
Correspondent
BETTER WATER, INC.
698 SWAN DR.
SMYRNA,  TN  37167
Correspondent Contact MICHAEL CLINE
Regulation Number876.5665
Classification Product Code
FIP  
Date Received06/17/2005
Decision Date 11/18/2005
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
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