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FDA 510(k) Application Details - K031502
Device Classification Name
Tank, Holding, Dialysis
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510(K) Number
K031502
Device Name
Tank, Holding, Dialysis
Applicant
USFILTER
725 WOOTEN RD.
COLORADO SPRINGS, CO 80915 US
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Contact
EDWARD L ARMSTRONG
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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
05/13/2003
Decision Date
08/27/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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