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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 K093828
Device Name KYPH X HV-R BONE CEMENT
Applicant
Medtronic, Inc.
1221 Crossman Ave.
Sunnyvale,  CA  94089
Applicant Contact MARY ROSE
Correspondent
Medtronic, Inc.
1221 Crossman Ave.
Sunnyvale,  CA  94089
Correspondent Contact MARY ROSE
Regulation Number888.3027
Classification Product Code
NDN  
Date Received12/14/2009
Decision Date 08/12/2010
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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