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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 K121313
Device Name MTF NEW BONE VOID FILLER
Original Applicant
MUSCULOSKELETAL TRANSPLANT FOUNDATION
125 may street
edison,  NJ  08837
Original Contact nancy joy
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
MBP  
Date Received05/02/2012
Decision Date 01/11/2013
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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