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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 K102913
Device Name FORCETRIAD
Applicant
Covidien, Formerly Valleylab, A Division of Tyco H
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact BEN CORDILEONE
Correspondent
Covidien, Formerly Valleylab, A Division of Tyco H
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact BEN CORDILEONE
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/01/2010
Decision Date 05/06/2011
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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