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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 K843950
Device Name LINK CEMENTLESS SCREW-IN ACETABULAR CUP
Original Applicant
WALDEMAR LINK GMBH & CO. KG
10 great meadow ln.
e. hanover,  NJ  07936
Original Contact ed schussler
Regulation Number888.3330
Classification Product Code
KWA  
Date Received10/09/1984
Decision Date 06/03/1985
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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