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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 K984158
Device Name P.F.C. MODULAR PLUS OFFSET TIBIAL TRAY
Applicant
DEPUY, INC.
700 ORTHOPAEDIC DR.
WARSAW,  IN  46581 -0988
Applicant Contact ARLENE C SAULL
Correspondent
DEPUY, INC.
700 ORTHOPAEDIC DR.
WARSAW,  IN  46581 -0988
Correspondent Contact ARLENE C SAULL
Regulation Number888.3560
Classification Product Code
JWH  
Date Received11/19/1998
Decision Date 01/28/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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