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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 K062000
Device Name HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH
Applicant
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242
Applicant Contact CAROL WALSH
Correspondent
Ethicon Endo-Surgery, Inc.
4545 Creek Rd.
Cincinnati,  OH  45242
Correspondent Contact CAROL WALSH
Classification Product Code
LFL  
Date Received07/17/2006
Decision Date 09/25/2006
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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