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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Electrosurgical
510(k) Number K050923
Device Name LIGHTWAVE INTEGRATED ELECTRODE ABLATOR AND LIGHT WAVE INTEGRATED ELECTRODE SUCTION ABLATOR
Applicant
Conmed Linvatec
11311 Concept Blvd.
Largo,  FL  33773
Applicant Contact ELIZABETH PAUL
Correspondent
Conmed Linvatec
11311 Concept Blvd.
Largo,  FL  33773
Correspondent Contact ELIZABETH PAUL
Regulation Number878.4400
Classification Product Code
JOS  
Subsequent Product Code
GEI  
Date Received04/13/2005
Decision Date 05/18/2005
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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