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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 K870923
Device Name SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX.
Original Applicant
PROTEK, INC.
5780 west 71st st.
indianapolis,  IN  46278
Original Contact kenneth epling
Regulation Number888.3330
Classification Product Code
KWA  
Date Received03/04/1987
Decision Date 09/14/1987
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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