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510(k) K143117

Wire Sterilization Package with Indicators by American Orthodontics — Product Code FRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2015
Date Received
October 30, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wrap, Sterilization
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type

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