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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 K910563
Device Name P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL
Applicant
Johnson & Johnson Orthopaedics, Inc.
Raynham,  MA  02767
Applicant Contact MARSHA J STONE
Correspondent
Johnson & Johnson Orthopaedics, Inc.
Raynham,  MA  02767
Correspondent Contact MARSHA J STONE
Regulation Number888.3560
Classification Product Code
JWH  
Date Received02/08/1991
Decision Date 05/23/1991
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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