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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 K213475
Device Name Elevo Snoring Intervention Set
Applicant
Zelegent, Inc.
4250 Executive Sq., Suite 675
La Jolla,  CA  92037
Applicant Contact David C. Humbert
Correspondent
Zelegent, Inc.
4250 Executive Sq., Suite 675
La Jolla,  CA  92037
Correspondent Contact David C. Humbert
Regulation Number872.5570
Classification Product Code
LRK  
Date Received10/29/2021
Decision Date 01/27/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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