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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 K120023
Device Name ZELTIQ COOLSCULPTING
Applicant
ZELTIQ AESTHETICS, INC.
4698 WILLOW ROAD
PLEASANTON,  CA  94588
Applicant Contact LOUIS-PIERRE MARCOUX
Correspondent
ZELTIQ AESTHETICS, INC.
4698 WILLOW ROAD
PLEASANTON,  CA  94588
Correspondent Contact LOUIS-PIERRE MARCOUX
Regulation Number878.4340
Classification Product Code
OOK  
Date Received01/03/2012
Decision Date 05/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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