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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 K143623
Device Name Narval Brux
Applicant
RESMED SAS
292, ALLEE JACQUES, MONOD
SAINT-PRIEST CEDEX,  FR 69791
Applicant Contact Larissa D'Andrea
Correspondent
RESMED CORP.
9001 SPECTRUM CENTER BOULEVARD
SAN DIEGO,  CA  92123
Correspondent Contact Allison C Komiyama
Classification Product Code
MQC  
Date Received12/22/2014
Decision Date 08/13/2015
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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