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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, antibiotic
510(k) Number K081163
Device Name SMARTSET GMV GENTAMICIN BONE CEMENT
Applicant
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46581 -0988
Applicant Contact SUZANA OTANO
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW,  IN  46581 -0988
Correspondent Contact SUZANA OTANO
Regulation Number888.3027
Classification Product Code
MBB  
Subsequent Product Code
LOD  
Date Received04/24/2008
Decision Date 05/14/2008
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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