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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 K101797
Device Name SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T
Applicant
Covidien, Formerly Valleylab, A Division of Tyco
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact DAVID M HORTON
Correspondent
Covidien, Formerly Valleylab, A Division of Tyco
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact DAVID M HORTON
Classification Product Code
LFL  
Date Received06/28/2010
Decision Date 02/24/2011
Decision Substantially Equivalent (SESE)
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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