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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 K083712
Device Name WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
Applicant
DIPURE, LLC.
1919 EDWARDS STREET
HOUSTON,  TX  77007
Applicant Contact TIM MARCO
Correspondent
DIPURE, LLC.
1919 EDWARDS STREET
HOUSTON,  TX  77007
Correspondent Contact TIM MARCO
Regulation Number876.5665
Classification Product Code
FIP  
Date Received12/15/2008
Decision Date 07/10/2009
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
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