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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 K252942
Device Name ShaeferH
Applicant
Shaeferh, LLC
45 St.Uart St.
2501
Boston,  MA  02116
Applicant Contact Andy Cheung
Correspondent
Shaeferh, LLC
45 St.Uart St.
2501
Boston,  MA  02116
Correspondent Contact Andy Cheung
Regulation Number872.5570
Classification Product Code
LRK  
Subsequent Product Code
LQZ  
Date Received09/15/2025
Decision Date 04/10/2026
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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