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510(k) K201781

Uni-FuZe-P Bone Putty by Zavation Medical Products, LLC — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 2020
Date Received
June 30, 2020
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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