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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 BOULEVARD
LARGO,  FL  33773 -4908
Applicant Contact ELIZABETH PAUL
Correspondent
CONMED LINVATEC
11311 CONCEPT BOULEVARD
LARGO,  FL  33773 -4908
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
Recalls CDRH Recalls
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