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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 K961685
Device Name P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)
Applicant
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767
Applicant Contact JOHN D FERROS
Correspondent
JOHNSON & JOHNSON PROFESSIONALS, INC.
325 PARAMOUNT DR.
RAYNHAM,  MA  02767
Correspondent Contact JOHN D FERROS
Regulation Number888.3560
Classification Product Code
JWH  
Date Received05/01/1996
Decision Date 07/10/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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