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510(k) K200614

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2020
Date Received
March 9, 2020
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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