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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 K854107
Device Name DIMENSION TOTAL HIP PROSTHESIS POROUS COATED
Applicant
KIRSCHNER MEDICAL CORP.
9690 DEERECO ROADD
TIMONIUM,  MD  21093
Applicant Contact SAN SON
Correspondent
KIRSCHNER MEDICAL CORP.
9690 DEERECO ROADD
TIMONIUM,  MD  21093
Correspondent Contact SAN SON
Regulation Number888.3320
Classification Product Code
JDL  
Date Received10/08/1985
Decision Date 03/10/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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