FDA 510(k) Application Details - K033021

Device Classification Name System, Thermal Regulating

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510(K) Number K033021
Device Name System, Thermal Regulating
Applicant KIMBERLY-CLARK CORP.
1400 HOLCOMB BRIDGE RD.
ROSWELL, GA 30076 US
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Contact RICHARD V WOLFE
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Regulation Number 870.5900

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Classification Product Code DWJ
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Date Received 09/26/2003
Decision Date 11/12/2003
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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