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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Bone, Vertebroplasty
510(k) Number K071927
Device Name MODIFICATION TO VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
Applicant
Depuy Spine, A Johnson & Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact SHARON STAROWICZ
Correspondent
Depuy Spine, A Johnson & Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact SHARON STAROWICZ
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
LOD  
Date Received07/12/2007
Decision Date 11/21/2007
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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