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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name bone cement
510(k) Number K041656
Device Name MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46581 -0988
Applicant Contact TIFFANI ROGERS
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46581 -0988
Correspondent Contact TIFFANI ROGERS
Regulation Number888.3027
Classification Product Code
LOD  
Subsequent Product Code
MBB  
Date Received06/18/2004
Decision Date 07/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
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