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FDA 510(k) Application Details - K110368
Device Classification Name
Filler, Bone Void, Calcium Compound
More FDA Info for this Device
510(K) Number
K110368
Device Name
Filler, Bone Void, Calcium Compound
Applicant
NovaBone Products, LLC
13631 PROGRESS BLVD
SUITE 600
ALACHUA, FL 32615 US
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Contact
DAVID M GAISSER
Other 510(k) Applications for this Contact
Regulation Number
888.3045
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Classification Product Code
MQV
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More FDA Info for this Product Code
Date Received
02/08/2011
Decision Date
04/14/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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