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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 K920034
Device Name DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC
Applicant
Pfizer Hospital Products Group, Inc.
359 Veterans Blvd.
Rutherford,  NJ  07070
Applicant Contact MARGARET F CROWE
Correspondent
Pfizer Hospital Products Group, Inc.
359 Veterans Blvd.
Rutherford,  NJ  07070
Correspondent Contact MARGARET F CROWE
Regulation Number888.3560
Classification Product Code
JWH  
Date Received01/06/1992
Decision Date 03/18/1992
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
Recalls CDRH Recalls
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