Narval Brux

Mouthguard, Prescription

RESMED SAS

The following data is part of a premarket notification filed by Resmed Sas with the FDA for Narval Brux.

Pre-market Notification Details

Device IDK143623
510k NumberK143623
Device Name:Narval Brux
ClassificationMouthguard, Prescription
Applicant RESMED SAS 292, ALLEE JACQUES, MONOD Saint-priest Cedex,  FR 69791
ContactLarissa D'andrea
CorrespondentAllison C Komiyama
RESMED CORP. 9001 SPECTRUM CENTER BOULEVARD San Diego,  CA  92123
Product CodeMQC  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-22
Decision Date2015-08-13
Summary:summary

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