FDA.report

510(k) K143623

Device
Narval Brux
Applicant
RESMED SAS
510(k) number
K143623
Product code
MQC  
Decision
Substantially Equivalent (SESE)
Decision date
2015-08-13
Date received
2014-12-22
Regulation
510(k) Premarket Notification
Classification name
Mouthguard, Prescription
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Dental
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Larissa D'Andrea
Address
292, Allee Jacques, Monod Saint-Priest Cedex FR 69791 69791

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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