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FDA 510(k) Application Details - K080899
Device Classification Name
System, Hypothermia, Intravenous, Cooling
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510(K) Number
K080899
Device Name
System, Hypothermia, Intravenous, Cooling
Applicant
MEDIVANCE, INC.
1172 CENTURY DR., SUITE 240
LOUISVILLE, CO 80027 US
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Contact
LYNNE ARONSON
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Regulation Number
870.5900
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Classification Product Code
NCX
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More FDA Info for this Product Code
Date Received
03/31/2008
Decision Date
08/07/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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