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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 K033563
Device Name SMARTSET GHV GENTAMICIN BONE CEMENT
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
warsaw,  IN  46581 -0988
Applicant Contact tiffani d rogers
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
warsaw,  IN  46581 -0988
Correspondent Contact tiffani d rogers
Regulation Number888.3027
Classification Product Code
LOD  
Subsequent Product Code
MBB  
Date Received11/12/2003
Decision Date 02/05/2004
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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