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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K003235
Device Name PE.R.I. II KNEE FRACTURE SYSTEM
Original Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw,  IN  46581 0988
Original Contact marcia j arentz
Regulation Number888.3030
Classification Product Code
HRS  
Date Received10/17/2000
Decision Date 11/06/2000
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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