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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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(k) Number K964878
Device Name ESOP S/C FEMORAL STEM
Applicant
Fournitures Hospitalieres
1700 Rockville Pike, Suite 450
Rockville,  MD  20852
Applicant Contact BEN VAN DER KOOIJ
Correspondent
Fournitures Hospitalieres
1700 Rockville Pike, Suite 450
Rockville,  MD  20852
Correspondent Contact BEN VAN DER KOOIJ
Regulation Number888.3353
Classification Product Code
MEH  
Subsequent Product Code
LZO  
Date Received12/05/1996
Decision Date 03/05/1998
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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