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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 K231138
Device Name Aniti-Snore Mouthguard+
Applicant
Oscimed SA
Allée du Quartz 3
2300 La Chaux-de-Fonds
Suisse,  CH 2300
Applicant Contact Jacques Magnin
Correspondent
Rook Quality Systems
1155 Mount Vernon Hwy, Suite 800
Dunwoody,  GA  30038
Correspondent Contact Michael Chen
Regulation Number872.5570
Classification Product Code
LRK  
Date Received04/21/2023
Decision Date 01/16/2024
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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