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FDA 510(k) Application Details - K022366
Device Classification Name
System, Hypothermia, Intravenous, Cooling
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510(K) Number
K022366
Device Name
System, Hypothermia, Intravenous, Cooling
Applicant
INNERCOOL THERAPIES
3931 SORRENTO VALLEY BLVD.
SAN DIEGO,, CA 92121 US
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Contact
STEVE REITZLER
Other 510(k) Applications for this Contact
Regulation Number
870.5900
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Classification Product Code
NCX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/22/2002
Decision Date
01/27/2003
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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