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FDA 510(k) Application Details - K023934
Device Classification Name
System, Thermal Regulating
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510(K) Number
K023934
Device Name
System, Thermal Regulating
Applicant
AVACORE TECHNOLOGIES, INC.
251 HIGH STREET, SUITE B
PALO ALTO, CA 94301 US
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CRAIG COOMBS
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Regulation Number
870.5900
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Classification Product Code
DWJ
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More FDA Info for this Product Code
Date Received
11/26/2002
Decision Date
01/23/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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