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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 K133314
FOIA Releasable 510(k) K133314
Device Name HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY
Applicant
Ethicon Endo-Surgery, LLC
4545 Creek Rd.
Cincinnati,  OH  45242
Applicant Contact BRIAN GODWIN
Correspondent
Ethicon Endo-Surgery, LLC
4545 Creek Rd.
Cincinnati,  OH  45242
Correspondent Contact BRIAN GODWIN
Classification Product Code
LFL  
Date Received10/28/2013
Decision Date 12/03/2013
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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