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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K141371
FOIA Releasable 510(k) K141371
Device Name SONICISION CORDLESS ULTRASONIC DISSECTOR
Applicant
Covidien, Formerly Valleylab, A Division of Tyco H
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact DAVID HORTON
Correspondent
Covidien, Formerly Valleylab, A Division of Tyco H
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact DAVID HORTON
Classification Product Code
LFL  
Date Received05/27/2014
Decision Date 08/07/2014
Decision Substantially Equivalent (SESE)
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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