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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 K181740
Device Name ZELTIQ CoolSculpting System
Applicant
ZELTIQ Aesthetics, Inc.
4410 Rosewood Drive
Pleasanton,  CA  94588
Applicant Contact Ewald Riechert
Correspondent
ZELTIQ Aesthetics, Inc.
4410 Rosewood Drive
Pleasanton,  CA  94588
Correspondent Contact Alex Chang
Regulation Number878.4340
Classification Product Code
OOK  
Date Received07/02/2018
Decision Date 08/29/2018
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
Recalls CDRH Recalls
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