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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, thermal regulating
510(k) Number K120849
Device Name HYBRID ARCTICGEL PAD
Original Applicant
MEDIVANCE, INC.
321 south taylor avenue
suite 200
louisville,  CO  80027
Original Contact lynne aronson
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received03/20/2012
Decision Date 07/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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