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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Prescription
510(k) Number K181361
Device Name Brux Night Guard
Applicant
Brux Night Guard
8201 Canoga Ave. #9066
Canoga Park,  CA  91309
Applicant Contact John Scalco
Correspondent
Brux Night Guard
8201 Canoga Ave. #9066
Canoga Park,  CA  91309
Correspondent Contact John Scalco
Classification Product Code
MQC  
Date Received05/23/2018
Decision Date 04/11/2019
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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