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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 K172452
Device Name Bruxor
Applicant
Sleep Specialties, LLC
2565 S. Las Vegas Blvd., Suite #184
Las Vegas,  NV  89109
Applicant Contact James S. Fallon
Correspondent
James Smith
28591 Springfield Dr.
Irvine,  CA  92677
Correspondent Contact James Smith
Classification Product Code
OBR  
Date Received08/14/2017
Decision Date 01/11/2018
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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