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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 K172223
Device Name SleepRight ProRx Custom Dental Guard
Applicant
Splintek, Inc.
15555 W. 108th St.
Lenexa,  KS  66219
Applicant Contact Samantha Schroeder
Correspondent
Splintek, Inc.
15555 W. 108th St.
Lenexa,  KS  66219
Correspondent Contact Samantha Schroeder
Classification Product Code
OBR  
Subsequent Product Code
MQC  
Date Received07/24/2017
Decision Date 11/17/2017
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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