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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 K870273
Device Name LACEY METAL BACKED PATELLA 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 Number888.3560
Classification Product Code
JWH  
Date Received01/27/1987
Decision Date 07/01/1987
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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