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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K072849
Device Name MODIFICATION TO THERMAGE THERMACOOL SYSTEM
Applicant
Thermage, Inc.
25881 Industrial Blvd.
Hayward,  CA  94545
Applicant Contact PAMELA M BUCKMAN
Correspondent
Thermage, Inc.
25881 Industrial Blvd.
Hayward,  CA  94545
Correspondent Contact PAMELA M BUCKMAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/04/2007
Decision Date 01/18/2008
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
Predetermined Change
Control Plan Authorized		 No
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