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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K081278
Device Name OMEGA 3 TROCHANTERIC STABILIZING PLATE
Applicant
Howmedica Osteonics Corp.
325 Corporate Dr.
Mahwah,  NJ  07430
Applicant Contact ANDREA DWYER
Correspondent
Howmedica Osteonics Corp.
325 Corporate Dr.
Mahwah,  NJ  07430
Correspondent Contact ANDREA DWYER
Regulation Number888.3030
Classification Product Code
KTT  
Date Received05/06/2008
Decision Date 05/29/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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