Soundly Anti Snoring Device

Device, Anti-snoring

Greystone IP Ltd

The following data is part of a premarket notification filed by Greystone Ip Ltd with the FDA for Soundly Anti Snoring Device.

Pre-market Notification Details

Device IDK220330
510k NumberK220330
Device Name:Soundly Anti Snoring Device
ClassificationDevice, Anti-snoring
Applicant Greystone IP Ltd Unit 322, Moat House, 54 Bloomfield Avenue Belfast,  IE BT5 5AD
ContactJudy Purvis
CorrespondentJudy Purvis
Greystone IP Ltd Unit 322, Moat House, 54 Bloomfield Avenue Belfast,  IE BT5 5AD
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-04
Decision Date2022-09-08

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