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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 K033634
Device Name EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED
Original Applicant
CENTERPULSE ORTHOPEDICS, INC.
9900 spectrum dr.
austin,  TX  78717
Original Contact audrey swearingen
Regulation Number888.3330
Classification Product Code
KWA  
Date Received11/19/2003
Decision Date 09/15/2004
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
Recalls CDRH Recalls
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