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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, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(k) Number K953510
Device Name HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS
Applicant
ENCORE ORTHOPEDICS, INC.
8920 BUSINESS PARK DR.
SUTIE 380
AUSTIN,  TX  78759
Applicant Contact J.D. WEBB
Correspondent
ENCORE ORTHOPEDICS, INC.
8920 BUSINESS PARK DR.
SUTIE 380
AUSTIN,  TX  78759
Correspondent Contact J.D. WEBB
Regulation Number888.3390
Classification Product Code
KWY  
Date Received07/26/1995
Decision Date 08/09/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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