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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 K120354
Device Name BETA-TCP GRANULES
Original Applicant
SKELETAL KINETICS, LLC
10201 bubb rd.
cupertino,  CA  95014 4167
Original Contact christine kuo
Regulation Number888.3045
Classification Product Code
MQV  
Date Received02/06/2012
Decision Date 03/21/2013
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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