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FDA 510(k) Application Details - K061513
Device Classification Name
System, Thermal Regulating
More FDA Info for this Device
510(K) Number
K061513
Device Name
System, Thermal Regulating
Applicant
SMITHS MEDICAL ASD, INC.
10 BOWMAN DR.
KEENE, NH 03431 US
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Contact
TIMOTHY J TALCOTT
Other 510(k) Applications for this Contact
Regulation Number
870.5900
More FDA Info for this Regulation Number
Classification Product Code
DWJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/01/2006
Decision Date
08/01/2006
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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