SOMNODENT HERBST; CLASSIC, FLEX

Device, Anti-snoring

SOMNOMED INC.

The following data is part of a premarket notification filed by Somnomed Inc. with the FDA for Somnodent Herbst; Classic, Flex.

Pre-market Notification Details

Device IDK130558
510k NumberK130558
Device Name:SOMNODENT HERBST; CLASSIC, FLEX
ClassificationDevice, Anti-snoring
Applicant SOMNOMED INC. 7460 Warren Pkwy Ste 190 Frisco,  TX  75034
ContactKathryn A Jayne
CorrespondentKathryn A Jayne
SOMNOMED INC. 7460 Warren Pkwy Ste 190 Frisco,  TX  75034
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-04
Decision Date2013-05-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851826007168 K130558 000
00851826007137 K130558 000
00851826007120 K130558 000
00851826007106 K130558 000
00851826007076 K130558 000
00851826007069 K130558 000

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