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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 K844482
Device Name MULLER TITANIUM BACKED ACETABULAR CUP COMPONENT
Original Applicant
ADVANCED BIOSEARCH ASSN.
3880 blackhawk rd.
danville,  CA  94506 4617
Original Contact barry m calvarese
Regulation Number888.3320
Classification Product Code
JDL  
Date Received11/19/1984
Decision Date 02/19/1985
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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