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FDA 510(k) Application Details - DEN090002
Device Classification Name
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510(K) Number
DEN090002
Device Name
ZELTIQ AESTHETICS DERMAL COOLING DEVICE
Applicant
ZELTIQ AESTHETICS
4698 WILLOW ROAD
PLEASANTON, CA 94588 US
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Contact
LOUIS-PIERRE MARCOUX
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Regulation Number
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Classification Product Code
OOK
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Date Received
10/13/2009
Decision Date
08/24/2010
Decision
DENG -
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type
Post-NSE
Reviewed By Third Party
N
Expedited Review
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