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FDA 510(k) Application Details - K981093
Device Classification Name
System, Thermal Regulating
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510(K) Number
K981093
Device Name
System, Thermal Regulating
Applicant
WESCO, INC.
921 SUNSET DR.
EAST PEORIA, IL 61611 US
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ARLEN C WEST
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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
03/26/1998
Decision Date
03/28/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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