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510(k) K090731

NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD by Novabone Products, LLC — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2009
Date Received
March 19, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type

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