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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 K032097
Device Name DEPUY ACE VERSANAIL TIBIAL NAIL
Applicant
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581
Applicant Contact TIFFANI ROGERS
Correspondent
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581
Correspondent Contact TIFFANI ROGERS
Regulation Number888.3020
Classification Product Code
HSB  
Date Received07/08/2003
Decision Date 08/08/2003
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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