ZQUIET MOUTHPIECE

Device, Anti-snoring

SLEEPING WELL, LLC

The following data is part of a premarket notification filed by Sleeping Well, Llc with the FDA for Zquiet Mouthpiece.

Pre-market Notification Details

Device IDK090503
510k NumberK090503
Device Name:ZQUIET MOUTHPIECE
ClassificationDevice, Anti-snoring
Applicant SLEEPING WELL, LLC 1468 HARWELL AVE. Crofton,  MD  21114
ContactYolanda Smith
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-02-25
Decision Date2009-03-10
Summary:summary

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