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FDA 510(k) Application Details - K140078
Device Classification Name
System, Thermal Regulating
More FDA Info for this Device
510(K) Number
K140078
Device Name
System, Thermal Regulating
Applicant
INSPIRATION HEALTHCARE LTD
GILDOR HOUSE, WEST STREET
EARL SHILTON, LEICESTER LE9 7EJ GB
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Contact
WAYNE IDDON
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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
01/13/2014
Decision Date
11/14/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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