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510(k) K103742

ACCELL EVO3 (FORMERLY ACCELL A2I) by Integra Life Sciences — Product Code MBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2011
Date Received
December 23, 2010
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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