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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K090094
FOIA Releasable 510(k) K090094
Device Name ZELTIQ SYSTEM
Applicant
Zeltiq Aesthetics
4698 Willow Rd.
Pleasanton,  CA  94588
Applicant Contact DONALD V JOHNSON
Correspondent
Zeltiq Aesthetics
4698 Willow Rd.
Pleasanton,  CA  94588
Correspondent Contact DONALD V JOHNSON
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
ILO   ISA  
Date Received01/14/2009
Decision Date 05/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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