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FDA 510(k) Application Details - K080908
Device Classification Name
System, Hypothermia, Intravenous, Cooling
More FDA Info for this Device
510(K) Number
K080908
Device Name
System, Hypothermia, Intravenous, Cooling
Applicant
INNERCOOL THERAPIES, INC.- A DELAWARE CORPORATION
6740 TOP GUN STREET
SAN DIEGO, CA 92121 US
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Contact
JENNIFER SPINELLA
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
04/01/2008
Decision Date
10/17/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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