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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 K152860
Device Name HELIXAR ELECTROSURGICAL GENERATOR WITH ARGON BEAM COAGULATION, HELIXAR MOBILE PEDESTAL
Applicant
CONMED CORPORATION
525 FRENCH ROAD
UTICA,  NY  13502
Applicant Contact LISA ANDERSON
Correspondent
CONMED CORPORATION
525 FRENCH ROAD
UTICA,  NY  13502
Correspondent Contact LISA ANDERSON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/30/2015
Decision Date 12/29/2015
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
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