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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 K935262
Device Name P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA
Applicant
Johnson & Johnson Orthopaedics, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact MARSHA J STONE
Correspondent
Johnson & Johnson Orthopaedics, Inc.
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact MARSHA J STONE
Regulation Number888.3560
Classification Product Code
JWH  
Date Received11/03/1993
Decision Date 06/03/1994
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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