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510(k) K182742

DB-CMF by Dimensional Bioceramics, LLC — Product Code GXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2019
Date Received
September 28, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Methyl Methacrylate For Cranioplasty
Device Class
Class II
Regulation Number
882.5300
Review Panel
NE
Submission Type

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