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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 K093463
Device Name AVAMAX VERTEBRAL BALLOON MODEL VBS1010, VBS1015, VBS1020
Applicant
CAREFUSION
1500 WAUKEGAN ROAD
waukegan,  IL  60085
Applicant Contact sharon nichols
Correspondent
CAREFUSION
1500 WAUKEGAN ROAD
waukegan,  IL  60085
Correspondent Contact sharon nichols
Regulation Number888.3027
Classification Product Code
NDN  
Subsequent Product Code
HRX  
Date Received11/06/2009
Decision Date 02/26/2010
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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