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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 uncemented acetabular component)
510(k) Number K003250
Device Name FMP METAL/METAL ACETABULAR INSERT
Original Applicant
ENCORE ORTHOPEDICS, INC.
9800 metric blvd.
austin,  TX  78758
Original Contact debbie de los santos
Regulation Number888.3330
Classification Product Code
KWA  
Date Received10/17/2000
Decision Date 01/25/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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