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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 K932911
Device Name ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT
Applicant
DOW CORNING WRIGHT
P.O. BOX 100
ARLINGTON,  TN  38002
Applicant Contact DIANN ATCHISON
Correspondent
DOW CORNING WRIGHT
P.O. BOX 100
ARLINGTON,  TN  38002
Correspondent Contact DIANN ATCHISON
Regulation Number888.3560
Classification Product Code
JWH  
Date Received06/16/1993
Decision Date 06/30/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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