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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 K173281
Device Name LigaSure Exact Dissector, Nano-coated
Applicant
Covidien
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact Celso Duran
Correspondent
Covidien
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact Celso Duran
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/16/2017
Decision Date 03/02/2018
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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