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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dermal cooling pack/vacuum/massager
510(k) Number K080521
Device Name ZELTIQ AESTHETICS DERMAL COOLING DEVICE
Original Applicant
ZELTIQ AESTHETICS
4698 willow road
pleasanton,  CA  94588
Original Contact louis-pierre marcoux
Regulation Number878.4340
Classification Product Code
OOK  
Date Received02/26/2008
Decision Date 08/24/2010
Decision de novo petitions granted (AN)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
FOI Item Approval Letter
Type De Novo Petitions Granted
Reviewed by Third Party No
Expedited Review No
Combination Product No
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