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FDA 510(k) Application Details - K113705
Device Classification Name
System, Thermal Regulating
More FDA Info for this Device
510(K) Number
K113705
Device Name
System, Thermal Regulating
Applicant
PINTLER MEDICAL
3220 S. HANFORD STREET
SEATTLE, WA 98144 US
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Contact
MARIBETH MACINTYRE-ELLIS
Other 510(k) Applications for this Contact
Regulation Number
870.5900
More FDA Info for this Regulation Number
Classification Product Code
DWJ
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More FDA Info for this Product Code
Date Received
12/16/2011
Decision Date
08/31/2012
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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