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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 K132512
Device Name HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE
Applicant
ETHICON ENDO-SURGERY, LLC
4545 CREEK RD.
CINCINNATI,  OH  45242
Applicant Contact DAVID LOCKE
Correspondent
ETHICON ENDO-SURGERY, LLC
4545 CREEK RD.
CINCINNATI,  OH  45242
Correspondent Contact DAVID LOCKE
Classification Product Code
LFL  
Date Received08/12/2013
Decision Date 10/24/2013
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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