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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 K081580
Device Name BEAMER ARGON SNARE PROBE
Applicant
Conmed Corporation
129 Concord Rd.
Bldg. #3
Billerica,  MA  01821
Applicant Contact KAREN PROVENCHER
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact KACHI ENYINNA
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/05/2008
Decision Date 06/19/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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