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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 K003183
Device Name THERMAGE THERMACOOL II SYSTEM
Applicant
Thermage, Inc.
4058 Point Eden Way
Hayward,  CA  94545 -3721
Applicant Contact KEITH MULLOWNEY
Correspondent
Thermage, Inc.
4058 Point Eden Way
Hayward,  CA  94545 -3721
Correspondent Contact KEITH MULLOWNEY
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/11/2000
Decision Date 12/08/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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