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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 K813599
Device Name 101-32 FEMORAL COMPONENT
Original Applicant
Regulation Number888.3320
Classification Product Code
Date Received12/28/1981
Decision Date 01/22/1982
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No