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510(k) K123633

TRS CRANIAL BONE VOID FILLER(TRS C-BVF) by Tissue Regeneration Systems, Inc. — Product Code GXR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2013
Date Received
November 23, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Burr Hole
Device Class
Class II
Regulation Number
882.5250
Review Panel
NE
Submission Type

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