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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 K140658
Device Name THERMOGARD DISPERSIVE ELECTRODES, THERMOGARD PLUS ABC DISPERSIVE ELECTRODES
Applicant
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Applicant Contact SANDY LECLAIR
Correspondent
Conmed Corporation
525 French Rd.
Utica,  NY  13502
Correspondent Contact SANDY LECLAIR
Regulation Number878.4400
Classification Product Code
GEI  
Date Received03/14/2014
Decision Date 07/10/2014
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
Recalls CDRH Recalls
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