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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
Applicant Contact EDWARD B SCHUSSLER
Correspondent
LINK AMERICA, INC.
C/O SURGICAL IMPLANTS, INC.
10 GREAT MEADOW LANE
EAST HANAVOR,  NJ  07936
Correspondent Contact EDWARD B SCHUSSLER
Regulation Number888.3320
Classification Product Code
JDL  
Date Received12/10/1985
Decision Date 03/05/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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