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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 K901626
Device Name H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED
Original Applicant
MED-TEK CORP.
6535 e. 82nd st.
suite 215
indianapolis,  IN  46250
Original Contact kenneth epling
Regulation Number888.3330
Classification Product Code
KWA  
Date Received04/09/1990
Decision Date 08/14/1990
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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