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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, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K061648
Device Name DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)
Applicant
DePuy Orthopaedics, Inc.
P.O. Box 988
Warsaw,  IN  46581 -0988
Applicant Contact NANCY FRIDDLE
Correspondent
DePuy Orthopaedics, Inc.
P.O. Box 988
Warsaw,  IN  46581 -0988
Correspondent Contact NANCY FRIDDLE
Regulation Number888.3560
Classification Product Code
NPJ  
Subsequent Product Codes
HRY   KRR  
Date Received06/13/2006
Decision Date 09/11/2006
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
Recalls CDRH Recalls
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