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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 K063748
Device Name THERMOMED 1.8
Applicant
Thermosurgery Technologies, Inc.
2901 W. Indian School Rd.
Phoenix,  AZ  85017 -4162
Applicant Contact GENE ZISCHKE
Correspondent
Thermosurgery Technologies, Inc.
2901 W. Indian School Rd.
Phoenix,  AZ  85017 -4162
Correspondent Contact GENE ZISCHKE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/19/2006
Decision Date 02/01/2007
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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