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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
Applicant
DEPUY, INC.
700 ORTHOPAEDIC DR.
WARSAW,  IN  46581 -0988
Applicant Contact LYNNETTE WHITAKER
Correspondent
DEPUY, INC.
700 ORTHOPAEDIC DR.
WARSAW,  IN  46581 -0988
Correspondent 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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