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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 K113090
Device Name LEVEEN SUPERSLIM NEEDLE ELECTRODE
Applicant
Boston Scientific Corporation
100 Boston Scientific Way
Marborough,  MA  01752
Applicant Contact ASHLEY PYLE
Correspondent
Boston Scientific Corporation
100 Boston Scientific Way
Marborough,  MA  01752
Correspondent Contact ASHLEY PYLE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/19/2011
Decision Date 03/15/2012
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
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