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510(k) K212721

Genex Bone Graft Substitute by Biocomposites, Ltd. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2022
Date Received
August 27, 2021
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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