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510(k) K172164

PROPEL Device by Propel Orthodontics, LLC — Product Code DZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2018
Date Received
July 18, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Driver, Wire, And Bone Drill, Manual
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

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