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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
Applicant
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.,
Warsaw,  IN  46582
Applicant Contact RHONDA MYER
Correspondent
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.,
Warsaw,  IN  46582
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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