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FDA 510(k) Application Details - K112427
Device Classification Name
Tank, Holding, Dialysis
More FDA Info for this Device
510(K) Number
K112427
Device Name
Tank, Holding, Dialysis
Applicant
ISOPURE CORP.
141 CITIZENS BLVD.
SIMPSONVILLE, KY 40067-6548 US
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Contact
KEVIN C GILLESPIE
Other 510(k) Applications for this Contact
Regulation Number
876.5820
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Classification Product Code
FIN
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More FDA Info for this Product Code
Date Received
08/23/2011
Decision Date
01/26/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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