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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 K970241
Device Name DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
Applicant
Depuy, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581 -0988
Applicant Contact SALLY FOUST
Correspondent
Depuy, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581 -0988
Correspondent Contact SALLY FOUST
Regulation Number888.3358
Classification Product Code
LPH  
Subsequent Product Codes
JDI   LZO  
Date Received01/22/1997
Decision Date 08/14/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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