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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 K070849
Device Name DEPUY GCK FEMORAL AND TIBIAL COMPONENTS
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46581 -0988
Applicant Contact NANCY FRIDDLE
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46581 -0988
Correspondent Contact NANCY FRIDDLE
Regulation Number888.3560
Classification Product Code
NPJ  
Subsequent Product Code
HRY  
Date Received03/28/2007
Decision Date 06/26/2007
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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