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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K980513
Device Name ARTICUL/EZE FEMORAL HEADS
Applicant
DePuy Orthopaedics, Inc.
P.O. Box 988
Warsaw,  IN  46581 -0988
Applicant Contact CHERYL K HASTINGS
Correspondent
DePuy Orthopaedics, Inc.
P.O. Box 988
Warsaw,  IN  46581 -0988
Correspondent Contact CHERYL K HASTINGS
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
LPH  
Date Received02/10/1998
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
Predetermined Change
Control Plan Authorized		 No
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