FDA 510(k) Application Details - K121720

Device Classification Name System, Thermal Regulating

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510(K) Number K121720
Device Name System, Thermal Regulating
Applicant WELKINS, LLC
1430 BLUE OAKS BLVD
SUITE 250
ROSEVILLE, CA 95747 US
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Contact CHRISTOPHER BLODGETT
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Regulation Number 870.5900

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Classification Product Code DWJ
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Date Received 06/12/2012
Decision Date 08/20/2012
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 Y
Expedited Review



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