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FDA 510(k) Application Details - K070112
Device Classification Name
System, Thermal Regulating
More FDA Info for this Device
510(K) Number
K070112
Device Name
System, Thermal Regulating
Applicant
MEDCOOL INC
5 TIMBER LANE
NORTH READING, MA 01864 US
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Contact
MAUREEN O'CONNELL
Other 510(k) Applications for this Contact
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
01/11/2007
Decision Date
07/13/2007
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
N
Expedited Review
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