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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
Sleep Specialties, LLC
2565 South Las Vegas Blvd.,Suite #184
Las Vegas,  NV  89109
Applicant Contact James S. Fallon
James Smith
28591 Springfield Drive
Laguna Niguel,  CA  92677
Correspondent Contact James Smith
Classification Product Code
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