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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name filler, bone void, calcium compound
510(K) Number K113791
Device Name B-GENIN, R-GENIN
Applicant
BERKELEY ADVANCED BIOMATERIALS, INC.
901 grayson st., suite 101
berkeley,  CA  94710
Contact francois genin
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
MBP  
Date Received12/22/2011
Decision Date 03/15/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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