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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Contact ARLEN C WEST
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Regulation Number 870.5900

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Classification Product Code DWJ
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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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