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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 K250028
Device Name Anti Snore Mouthpiece
Applicant
Dongguan Yiyao Science & Technology Development Co., Ltd.
Rm.501, #11 Shennan Yiheng St., Shenxiang, Qishi Town
Dongguan,  CN 523516
Correspondent
Dongguan Yiyao Science & Technology Development Co., Ltd.
Rm.501, #11 Shennan Yiheng St., Shenxiang, Qishi Town
Dongguan,  CN 523516
Correspondent Contact Xianzhao Tang
Regulation Number872.5570
Classification Product Code
LRK  
Date Received01/06/2025
Decision Date 10/03/2025
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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