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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, Porous Uncemented
510(k) Number K952740
Device Name DEPUY DURALOC 400 ACETABULAR CUP
Applicant
Depuy, Inc.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw,  IN  46581
Applicant Contact CHERYL HASTINGS
Correspondent
Depuy, Inc.
P.O. Box 988
700 Orthopaedic Dr.
Warsaw,  IN  46581
Correspondent Contact CHERYL HASTINGS
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Code
JDI  
Date Received06/15/1995
Decision Date 08/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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