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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 K112857
Device Name INTERFACE BONE VOID FILLER
Applicant
BIOSTRUCTURES, LLC
11234 el camino real
suite 200
san diego,  CA  92130
Contact kevin a thomas
Regulation Number888.3045
Classification Product Code
MQV  
Date Received09/30/2011
Decision Date 12/13/2011
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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