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510(k) K200752

DB-Orthopedics by Dimensional Bioceramics, LLC — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2020
Date Received
March 23, 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

Other clearances by Dimensional Bioceramics, LLC

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  • K171161 — Dimensional Bioceramics Calcium Sulfate Device (DB-CSD) (September 25, 2017)

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