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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, Femorotibial, Constrained, Cemented, Metal/Polymer
510(k) Number K910596
Device Name DCW MODULAR DISTAL FEMORAL SYSTEM
Applicant
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Applicant Contact DIANE D PATTON
Correspondent
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Correspondent Contact DIANE D PATTON
Regulation Number888.3510
Classification Product Code
KRO  
Date Received02/12/1991
Decision Date 05/29/1991
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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