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510(k) K150392

PROPEL device by Propel Orthodontics, LLC — Product Code DZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2015
Date Received
February 18, 2015
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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