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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 K060515
FOIA Releasable 510(k) K060515
Device Name DEPUY PFC SIGMA KNEE PROSTHESIS
Applicant
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr., P.O. Box 988
Warsaw,  IN  46581 -0988
Applicant Contact STEVEN J WENTWORTH
Correspondent
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr., P.O. Box 988
Warsaw,  IN  46581 -0988
Correspondent Contact STEVEN J WENTWORTH
Regulation Number888.3560
Classification Product Code
JWH  
Date Received02/27/2006
Decision Date 03/23/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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