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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 K954928
Device Name PORTABLE REVERSE OSMOSIS MACHINE
Applicant
BETTER WATER, INC.
698 SWAN DR.
SMYRNA,  TN  37167
Applicant Contact MIKE CLINE
Correspondent
BETTER WATER, INC.
698 SWAN DR.
SMYRNA,  TN  37167
Correspondent Contact MIKE CLINE
Regulation Number876.5665
Classification Product Code
FIP  
Date Received10/26/1995
Decision Date 01/24/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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