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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
Applicant
ENCORE ORTHOPEDICS, INC.
8920 business park dr.
sutie 380
austin,  TX  78759
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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