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510(k) K190271

FiteBac Cavity Cleanser by Largent Health, LLC — Product Code LBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2020
Date Received
February 8, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Varnish, Cavity
Device Class
Class II
Regulation Number
872.3260
Review Panel
DE
Submission Type

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