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FDA 510(k) Application Details - K100671
Device Classification Name
Bone Grafting Material, Synthetic
More FDA Info for this Device
510(K) Number
K100671
Device Name
Bone Grafting Material, Synthetic
Applicant
NovaBone Products, LLC
13631 PROGRESS BLVD
SUITE 600
ALACHUA, FL 32615 US
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Contact
DAVID M GAISSER
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Regulation Number
872.3930
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Classification Product Code
LYC
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More FDA Info for this Product Code
Date Received
03/09/2010
Decision Date
03/30/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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