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FDA 510(k) Application Details - K152946
Device Classification Name
System, Hypothermia, Intravenous, Cooling
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510(K) Number
K152946
Device Name
System, Hypothermia, Intravenous, Cooling
Applicant
SEIRATHERM GMBH
BEETHOVEN STREET. 10
91074 HERZOGENAURACH 13033 DE
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Contact
MATTHIAS ROTH
Other 510(k) Applications for this Contact
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
10/06/2015
Decision Date
09/15/2016
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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