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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 K072203
Device Name HARMONIC 10CM COMBINATION HOOK BLADE
Applicant
ETHICON ENDO-SURGERY, LLC
4545 CREEK RD.
CINCINNATI,  OH  45242
Applicant Contact ELIZABETH MILLER
Correspondent
ETHICON ENDO-SURGERY, LLC
4545 CREEK RD.
CINCINNATI,  OH  45242
Correspondent Contact ELIZABETH MILLER
Classification Product Code
LFL  
Date Received08/08/2007
Decision Date 09/25/2007
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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