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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 K222475
Device Name SNOR LOCK
Applicant
Solbaro Co., Ltd.
4th Floor 137, Janggam-Ro
Gamgok-Myeon, Eumseong-Gun,  KR 27603
Applicant Contact Donghoon Kim
Correspondent
Solbaro Co., Ltd.
4th Floor 137, Janggam-Ro
Gamgok-Myeon, Eumseong-Gun,  KR 27603
Correspondent Contact Jinwook Seo
Regulation Number872.5570
Classification Product Code
LRK  
Date Received08/16/2022
Decision Date 11/10/2022
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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