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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 K870867
Device Name KM-4(TM) METAL-BACKED ACETABULAR CUP
Applicant
KIRSCHNER MEDICAL CORP.
9690 deereco roadd
timonium,  MD  21093
Applicant Contact sam son
Correspondent
KIRSCHNER MEDICAL CORP.
9690 deereco roadd
timonium,  MD  21093
Correspodent Contact sam son
Regulation Number888.3320
Classification Product Code
JDL  
Date Received03/03/1987
Decision Date 05/08/1987
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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