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FDA 510(k) Application Details - K040632
Device Classification Name
System, Thermal Regulating
More FDA Info for this Device
510(K) Number
K040632
Device Name
System, Thermal Regulating
Applicant
SMITHS MEDICAL ASD, INC.
160 WEYMOUTH ST.
ROCKLAND, MA 02370 US
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VERNON TRIMBLE
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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
03/10/2004
Decision Date
04/27/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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