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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 K854935
Device Name LINK METAL-BACKED ACETABULAR CUPS
Applicant
LINK AMERICA, INC.
c/o surgical implants, inc.
10 great meadow lane
east hanavor,  NJ  07936
Contact edward b schussler
Regulation Number888.3320
Classification Product Code
JDL  
Date Received12/10/1985
Decision Date 03/05/1986
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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