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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 K143654
Device Name Valleylab LS10 Generator
Applicant
COVIDIEN LLC
15 HAMPSHIRE STREET
MANSFIELD,  MA  02048
Applicant Contact DONALD HENTON
Correspondent
COVIDIEN LLC
5920 LONGBOW DRIVE
BOULDER,  CO  80301
Correspondent Contact DONALD HENTON
Regulation Number878.4400
Classification Product Code
GEI  
Date Received12/23/2014
Decision Date 04/03/2015
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
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