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510(k) K090177

INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE by Inion OY — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 20, 2009
Date Received
January 23, 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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