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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, Uncemented
510(k) Number K994146
Device Name EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP
Applicant
Plus Orthopedics
200 Gregory Ln.
Suite C-100
Pleasant Hill,  CA  94553
Applicant Contact DAVID W SCHLERF
Correspondent
Plus Orthopedics
200 Gregory Ln.
Suite C-100
Pleasant Hill,  CA  94553
Correspondent Contact DAVID W SCHLERF
Regulation Number888.3360
Classification Product Code
LWJ  
Subsequent Product Code
LZO  
Date Received12/08/1999
Decision Date 12/11/2000
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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