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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 K081155
Device Name SMARTSET MV BONE CEMENT
Applicant
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581
Applicant Contact SUZANA OTANO
Correspondent
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr.
Warsaw,  IN  46581
Correspondent Contact SUZANA OTANO
Regulation Number888.3027
Classification Product Code
LOD  
Date Received04/23/2008
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 No
Predetermined Change
Control Plan Authorized		 No
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