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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Wrist, Semi-Constrained
510(k) Number K872502
Device Name M.W.P. WRIST PROSTHESIS
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 Number888.3800
Classification Product Code
KWM  
Date Received06/24/1987
Decision Date 07/23/1987
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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