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510(k) K182823

PRODENSE Bone Graft Substitute by Wrightmedicaltechnologyinc — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 2018
Date Received
October 4, 2018
Clearance Type
Special
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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