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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 K100597
Device Name HARMONIC FOCUS SHEARS
Applicant
Ethicon Endo-Surgery, LLC
4545 Creek Rd.
Blue Ash,  OH  45242
Applicant Contact MARCIA ARENTZ
Correspondent
Ethicon Endo-Surgery, LLC
4545 Creek Rd.
Blue Ash,  OH  45242
Correspondent Contact MARCIA ARENTZ
Classification Product Code
LFL  
Subsequent Product Code
GEI  
Date Received03/02/2010
Decision Date 04/07/2010
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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