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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 K191033
Device Name LunaGuard Nighttime Dental Protector
McKeon Products
25460 Guenther
Warren,  MI  48091
Applicant Contact Devin Benner
Right Submission LLC
59 High Street
Newton,  MA  02464
Correspondent Contact Elizabeth FitzGerald
Classification Product Code
Date Received04/18/2019
Decision Date 08/05/2019
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No