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510(k) K173933

Sorrento Bioglass Bone Graft Substitute by Xenco Medical, LLC — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2018
Date Received
December 26, 2017
Clearance Type
Traditional
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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