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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, Femoral Component, Cemented, Metal
510(k) Number K874575
Device Name PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
Applicant
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Applicant Contact LIPSCOMB, PHD
Correspondent
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Correspondent Contact LIPSCOMB, PHD
Regulation Number888.3360
Classification Product Code
JDG  
Date Received11/06/1987
Decision Date 01/07/1988
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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