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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 K120476
Device Name MACROLYTE DISPERSIVE ELECTRODE
Applicant
CONMED CORPORATION
14603 E. FREMONT AVE.
CENTENNIAL,  CO  80112
Applicant Contact SHAWN RIEDEL
Correspondent
CONMED CORPORATION
14603 E. FREMONT AVE.
CENTENNIAL,  CO  80112
Correspondent Contact SHAWN RIEDEL
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
JOS  
Date Received02/16/2012
Decision Date 06/12/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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