SOMNOBRUX SPLINTS

Mouthguard, Prescription

SOMNOMED INC

The following data is part of a premarket notification filed by Somnomed Inc with the FDA for Somnobrux Splints.

Pre-market Notification Details

Device IDK102909
510k NumberK102909
Device Name:SOMNOBRUX SPLINTS
ClassificationMouthguard, Prescription
Applicant SOMNOMED INC 7460 WARREN PARKWAY SUITE 190 Frisco,  TX  75034
ContactBradley Southworth
CorrespondentBradley Southworth
SOMNOMED INC 7460 WARREN PARKWAY SUITE 190 Frisco,  TX  75034
Product CodeMQC  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-10-01
Decision Date2011-12-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851826007151 K102909 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.