MmRNA Appliance

Device, Anti-snoring

Vivos Therapeutics, Inc. (formerly Vivos Biotechnologies, I)

The following data is part of a premarket notification filed by Vivos Therapeutics, Inc. (formerly Vivos Biotechnologies, I) with the FDA for Mmrna Appliance.

Pre-market Notification Details

Device IDK210203
510k NumberK210203
Device Name:MmRNA Appliance
ClassificationDevice, Anti-snoring
Applicant Vivos Therapeutics, Inc. (formerly Vivos Biotechnologies, I) 9137 S. Ridgeline Blvd. Suite 135 Highland Ranch,  CO  80129
ContactCatheryn Bonar
CorrespondentColette Cozean
Colette Cozean, PhD 21581 Midcrest Dr. Lake Forest,  CA  92630
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-26
Decision Date2021-08-19

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