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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 K120279
Device Name NANOFUSE DBM
Original Applicant
NANOTHERAPEUTICS
13859 progress blvd
suite 300
alachua,  FL  32615
Original Contact gregg ritter
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
MBP  
Date Received01/30/2012
Decision Date 04/06/2012
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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