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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 K013639
Device Name THERMAGE THERMACOOL TC SYSTEM
Applicant
THERMAGE, INC.
4058 POINT EDEN WAY
HAYWARD,  CA  94545 -3721
Applicant Contact PAMELA M BUCKMAN
Correspondent
THERMAGE, INC.
4058 POINT EDEN WAY
HAYWARD,  CA  94545 -3721
Correspondent Contact PAMELA M BUCKMAN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/05/2001
Decision Date 01/29/2002
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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