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FDA 510(k) Application Details - K081936
Device Classification Name
System, Hypothermia, Intravenous, Cooling
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510(K) Number
K081936
Device Name
System, Hypothermia, Intravenous, Cooling
Applicant
ALSIUS CORP.
15770 LAGUNA CANYON, SUITE 150
IRVINE, CA 92618 US
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Contact
JOHN RIOLO
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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
07/07/2008
Decision Date
08/13/2008
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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