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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 K132817
Device Name KIVA VCF TREATMENT SYSTEM
Applicant
Benvenue Medical, Inc.
1171 Barroilhet Dr.
Hillsborough,  CA  94010
Applicant Contact CINDY DOMECUS, R.A.C. (US & EU)
Correspondent
Benvenue Medical, Inc.
1171 Barroilhet Dr.
Hillsborough,  CA  94010
Correspondent Contact CINDY DOMECUS, R.A.C. (US & EU)
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
LOD  
Date Received09/09/2013
Decision Date 01/24/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Clinical Trials NCT01123512
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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