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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 K021109
Device Name ESOP CO-CR FEMORAL HEADS
Applicant
Fournitures Hospitalieres
C/O Pharmanet, Inc.
815 Connecticut Ave. NW Suite 800
Washington,  DC  20006
Applicant Contact ANDRE WEITH
Correspondent
Fournitures Hospitalieres
C/O Pharmanet, Inc.
815 Connecticut Ave. NW Suite 800
Washington,  DC  20006
Correspondent Contact ANDRE WEITH
Regulation Number888.3358
Classification Product Code
LPH  
Date Received04/05/2002
Decision Date 06/12/2002
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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