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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 K123282
Device Name DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS
Applicant
ULTRAPURE & INDUSTRIAL SERVICES LLC
4429 MINT WAY
DALLAS,  TX  75236
Applicant Contact GREG FRANKS
Correspondent
ULTRAPURE & INDUSTRIAL SERVICES LLC
4429 MINT WAY
DALLAS,  TX  75236
Correspondent Contact GREG FRANKS
Regulation Number876.5665
Classification Product Code
FIP  
Date Received10/22/2012
Decision Date 04/25/2013
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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