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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 K852369
Device Name LIDGRER-LUND ACETABULAR SOCKETS
Applicant
LINK AMERICA, INC.
C/O SURGICAL IMPLANTS, INC.
10 GREAT MEADOW LANE
east hanavor,  NJ  07936
Applicant Contact ed schussler
Correspondent
LINK AMERICA, INC.
C/O SURGICAL IMPLANTS, INC.
10 GREAT MEADOW LANE
east hanavor,  NJ  07936
Correspondent Contact ed schussler
  No 510(k) holder with active listings identified
Current 510(k) Holder
No 510(k) holder with active listings identified
Regulation Number888.3320
Classification Product Code
JDL  
Date Received06/04/1985
Decision Date 06/18/1985
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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