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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 K915512
Device Name DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS
Applicant
PFIZER HOSPITAL PRODUCTS GROUP, INC.
359 VETERANS BLVD.
RUTHERFORD,  NJ  07070
Applicant Contact MARGARET CROWE
Correspondent
PFIZER HOSPITAL PRODUCTS GROUP, INC.
359 VETERANS BLVD.
RUTHERFORD,  NJ  07070
Correspondent Contact MARGARET CROWE
Regulation Number888.3560
Classification Product Code
JWH  
Date Received12/09/1991
Decision Date 08/18/1992
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
Recalls CDRH Recalls
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