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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 uncemented acetabular component)
510(k) Number K003523
Device Name DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
Original Applicant
DEPUY ORTHOPAEDICS, INC.
p.o. box 988
warsaw,  IN  46581 -0988
Original Contact lynnette whitaker
Regulation Number888.3330
Classification Product Code
KWA  
Date Received11/15/2000
Decision Date 12/13/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
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