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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 K060419
Device Name CONCERTO BIPOLAR NEEDLE ELECTRODE
Applicant
Boston Scientific Corp
One Boston Scientific Pl.
Natick,  MA  01760 -1573
Applicant Contact NICHOLAS CONDAKES
Correspondent
Boston Scientific Corp
One Boston Scientific Pl.
Natick,  MA  01760 -1573
Correspondent Contact NICHOLAS CONDAKES
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/17/2006
Decision Date 03/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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