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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 uncemented acetabular component)
510(k) Number K852351
Device Name KIRSCHNER SELF-TAPPING ACETABULAR CUP
Original Applicant
KIRSCHNER MEDICAL CORP.
9690 deereco roadd
timonium,  MD  21093
Original Contact sam son
Regulation Number888.3330
Classification Product Code
KWA  
Date Received05/31/1985
Decision Date 08/09/1985
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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