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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 K150566
Device Name Oniris
Applicant
SAS Oniris
704 Avenue Roger Salengro
CHAVILLE,  FR 92370
Applicant Contact Thibault Vincent
Correspondent
SAS Oniris
704 Avenue Roger Salengro
CHAVILLE,  FR 92370
Correspondent Contact Thibault Vincent
Regulation Number872.5570
Classification Product Code
LRK  
Date Received03/06/2015
Decision Date 03/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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