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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 K021299
Device Name CONMED HEATWAVE HAND-CONTROLLED ELETRODE
Applicant
Conmedcorp
525 French Rd.
Utica,  NY  13502
Applicant Contact IRA D DUESLER
Correspondent
Conmedcorp
525 French Rd.
Utica,  NY  13502
Correspondent Contact IRA D DUESLER
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
HRX  
Date Received04/24/2002
Decision Date 06/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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