FDA 510(k) Application Details - K230947

Device Classification Name Device, Anti-Snoring

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510(K) Number K230947
Device Name Device, Anti-Snoring
Applicant Vivos Therapeutics, Inc
300 S. 5th Street
Murray, KY 42017 US
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Contact Kimberly Griffith
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Regulation Number 872.5570

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Classification Product Code LRK
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Date Received 04/04/2023
Decision Date 11/28/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K230947


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