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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 K980368
Device Name DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEM
Original Applicant
DEPUY, INC.
700 orthopaedic dr.
warsaw,  IN  46581 -0988
Original Contact lynnette whitaker
Regulation Number888.3030
Classification Product Code
HRS  
Date Received01/30/1998
Decision Date 04/14/1998
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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