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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 K070359
Device Name DEPUY ASR TAPER SLEEVE ADAPTER
Original Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw,  IN  46582
Original Contact rhonda myer
Regulation Number888.3330
Classification Product Code
KWA  
Date Received02/07/2007
Decision Date 03/06/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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