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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, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
510(k) Number K954481
Device Name P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM
Applicant
Johnson & Johnson Professionals, Inc.
Rte. 202 N.
Raritan,  NJ  08869
Applicant Contact ANNE M GRIFFIN
Correspondent
Johnson & Johnson Professionals, Inc.
Rte. 202 N.
Raritan,  NJ  08869
Correspondent Contact ANNE M GRIFFIN
Regulation Number888.3530
Classification Product Code
HRY  
Date Received09/27/1995
Decision Date 10/10/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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