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510(k) K152071

NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only) by Novabone Products, LLC — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2015
Date Received
July 27, 2015
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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