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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 K181107
Device Name Elevo® Kit Snoring Intervention Device
Applicant
Zelegent, Inc.
5151 California Ave.
Irvine,  CA  92617
Applicant Contact David C. Humbert
Correspondent
Zelegent, Inc.
5151 California Ave.
Irvine,  CA  92617
Correspondent Contact David C. Humbert
Regulation Number872.5570
Classification Product Code
LRK  
Date Received04/26/2018
Decision Date 12/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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