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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
510(k) Number K120005
Device Name ACDS
Applicant
ISOPURE CORP.
141 CITIZENS BLVD.
SIMPSONVILLE,  KY  40067 -6548
Applicant Contact KEVIN GILLESPIE
Correspondent
ISOPURE CORP.
141 CITIZENS BLVD.
SIMPSONVILLE,  KY  40067 -6548
Correspondent Contact KEVIN GILLESPIE
Regulation Number876.5820
Classification Product Code
KPO  
Date Received01/03/2012
Decision Date 03/29/2012
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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