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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 K180149
Device Name Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide
Applicant
Covidien, LLC
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact Nancy Sauer
Correspondent
Covidien, LLC
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact Nancy Sauer
Classification Product Code
LFL  
Date Received01/19/2018
Decision Date 03/26/2018
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
Recalls CDRH Recalls
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