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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 K250122
Device Name SleepRight Snore Aid
Applicant
Splintek, Inc.
15555 W. 108th St.
Lenexa,  KS  66219
Applicant Contact Thomas Brown
Correspondent
Splintek, Inc.
15555 W. 108th St.
Lenexa,  KS  66219
Correspondent Contact Thomas Brown
Regulation Number872.5570
Classification Product Code
LRK  
Date Received01/17/2025
Decision Date 05/19/2025
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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