SOMNOMED MAS RXA

Device, Anti-snoring

SOMNOMED LTD

The following data is part of a premarket notification filed by Somnomed Ltd with the FDA for Somnomed Mas Rxa.

Pre-market Notification Details

Device IDK050592
510k NumberK050592
Device Name:SOMNOMED MAS RXA
ClassificationDevice, Anti-snoring
Applicant SOMNOMED LTD PO BOX 560 Stillwater,  MN  55082
ContactElaine Duncan
CorrespondentElaine Duncan
SOMNOMED LTD PO BOX 560 Stillwater,  MN  55082
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-08
Decision Date2005-07-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00851826007113 K050592 000
00851826007021 K050592 000

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