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U.S. Department of Health and Human Services

Device Classification under Section 513(f)(2)(de novo)

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Device Classification Name dermal cooling pack/vacuum/massager
De Novo Number DEN090002
510(K) Number K080521
Device Name ZELTIQ AESTHETICS DERMAL COOLING DEVICE
Requester
ZELTIQ AESTHETICS
4698 willow road
pleasanton,  CA  94588
Contact louis-pierre marcoux
Regulation Number878.4340
Classification Product Code
OOK  
Date Received10/13/2009
Decision Date 08/24/2010
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Reclassification Order Reclassification Order
Type Post-NSE
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