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510(k) K063685

OPTECURE; OPTECURE + CCC by Exactech, Inc. — Product Code MBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2007
Date Received
December 12, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type

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