FBCC Night Guard

Mouthguard, Over-the-counter


The following data is part of a premarket notification filed by Fbcc Inc with the FDA for Fbcc Night Guard.

Pre-market Notification Details

Device IDK221369
510k NumberK221369
Device Name:FBCC Night Guard
ClassificationMouthguard, Over-the-counter
Applicant FBCC Inc 6711 S Sepulveda Blvd, Unit 602 Los Angeles,  CA  90045
ContactPablo Osorio
CorrespondentElisabeth Miller
Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston,  TX  77043
Product CodeOBR  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-12
Decision Date2022-11-18

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