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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Over-The-Counter
510(k) Number K193577
Device Name SleepRight ProRx Custom Dental Guard
Applicant
Splintek, Inc.
15555 W. 108th St.
Lenexa,  KS  66219
Applicant Contact Thomas W Brown
Correspondent
Splintek, Inc.
15555 W. 108th St.
Lenexa,  KS  66219
Correspondent Contact Thomas W Brown
Classification Product Code
OBR  
Subsequent Product Code
MQC  
Date Received12/23/2019
Decision Date 06/01/2020
Decision Substantially Equivalent (SESE)
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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