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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 K073413
Device Name DEPUY ASR 300 ACETABULAR CUP SYSTEM
Original Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw,  IN  46581 0988
Original Contact dawn sinclair
Regulation Number888.3330
Classification Product Code
KWA  
Date Received01/04/2008
Decision Date 01/30/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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