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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 K920186
Device Name WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
Applicant
BETTER WATER, INC.
607 SWAN DRIVE, STE.E
SMYRNA,  TN  37167
Applicant Contact BOB CLINE
Correspondent
BETTER WATER, INC.
607 SWAN DRIVE, STE.E
SMYRNA,  TN  37167
Correspondent Contact BOB CLINE
Regulation Number876.5665
Classification Product Code
FIP  
Date Received01/14/1992
Decision Date 06/13/1995
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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