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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 K102470
FOIA Releasable 510(k) K102470
Device Name LUGASURE CURVED, SMALL JAW, OPEN SEALER/DIVIDER
Applicant
Covidien, Formerly Valleylab,
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact DAVID M HORTON
Correspondent
Covidien, Formerly Valleylab,
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact DAVID M HORTON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received08/30/2010
Decision Date 02/07/2011
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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