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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 cemented acetabular component)
510(k) Number K950542
Device Name METAL BACKED ACETABULAR COMPONENT
Original Applicant
ENCORE ORTHOPEDICS, INC.
8920 business park dr.
sutie 380
austin,  TX  78759
Original Contact j. d webb
Regulation Number888.3320
Classification Product Code
JDL  
Date Received02/07/1995
Decision Date 05/25/1995
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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