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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.
Applicant
PROTEK, INC.
5780 WEST 71ST ST.
INDIANAPOLIS,  IN  46278
Applicant Contact KENNETH EPLING
Correspondent
PROTEK, INC.
5780 WEST 71ST ST.
INDIANAPOLIS,  IN  46278
Correspondent Contact KENNETH EPLING
Regulation Number888.3330
Classification Product Code
KWA  
Date Received03/04/1987
Decision Date 09/14/1987
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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