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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 Ln.
East Hanavor,  NJ  07936
Applicant Contact ED SCHUSSLER
Correspondent
Link America, Inc.
C/O Surgical Implants, Inc.
10 Great Meadow Ln.
East Hanavor,  NJ  07936
Correspondent Contact ED SCHUSSLER
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
Predetermined Change
Control Plan Authorized		 No
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