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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K033329
Device Name DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS
Applicant
Depuy, Inc.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw,  IN  46581
Applicant Contact RHONDA MYER
Correspondent
Depuy, Inc.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw,  IN  46581
Correspondent Contact RHONDA MYER
Regulation Number888.3020
Classification Product Code
HSB  
Date Received10/16/2003
Decision Date 11/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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