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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Anti-Snoring
510(k) Number K210203
Device Name mmRNA appliance
Applicant
Vivos Therapeutics, Inc. (formerly Vivos Biotechnologies, I)
9137 S. Ridgeline Blvd. Suite 135
Highland Ranch,  CO  80129
Applicant Contact Catheryn Bonar
Correspondent
Colette Cozean, PhD
21581 Midcrest Dr.
Lake Forest,  CA  92630
Correspondent Contact Colette Cozean
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Code
LQZ  
Date Received01/26/2021
Decision Date 08/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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