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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, Hemi-, Femoral, Metal
510(k) Number K884889
Device Name MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.
Applicant
Protek, Inc.
5780 W. 71st St.
Indianapolis,  IN  46278
Applicant Contact KENNETH EPLING
Correspondent
Protek, Inc.
5780 W. 71st St.
Indianapolis,  IN  46278
Correspondent Contact KENNETH EPLING
Regulation Number888.3360
Classification Product Code
KWL  
Date Received11/22/1988
Decision Date 02/27/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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