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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 K040191
Device Name BICONTACT HIP STEM AND FEMORAL HEAD
Applicant
Aesculap
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Applicant Contact JOYCE KILROY
Correspondent
Aesculap
3 773 Corporate Pkwy.
Center Valley,  PA  18034
Correspondent Contact JOYCE KILROY
Regulation Number888.3358
Classification Product Code
LPH  
Date Received01/28/2004
Decision Date 08/25/2004
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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