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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tank, holding, dialysis
510(k) Number K112427
Device Name BICARB MIXING AND DISTRIBUTION SYSTEM
Applicant
ISOPURE CORP.
141 CITIZENS BLVD.
SIMPSONVILLE,  KY  40067 -6548
Applicant Contact KEVIN C GILLESPIE
Correspondent
ISOPURE CORP.
141 CITIZENS BLVD.
SIMPSONVILLE,  KY  40067 -6548
Correspondent Contact KEVIN C GILLESPIE
Regulation Number876.5820
Classification Product Code
FIN  
Date Received08/23/2011
Decision Date 01/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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