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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K894504
Device Name WHITESIDE ORTHOLOC M.A. TIBIAL BASE
Applicant
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Applicant Contact DIANE DEERE
Correspondent
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Correspondent Contact DIANE DEERE
Regulation Number888.3560
Classification Product Code
JWH  
Date Received07/19/1989
Decision Date 10/17/1989
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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