ZQuiet Advance

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 Advance.

Pre-market Notification Details

Device IDK213088
510k NumberK213088
Device Name:ZQuiet Advance
ClassificationDevice, Anti-snoring
Applicant Sleeping Well, LLC 138 Steeplebush Rd. Shelburne,  VT  05482
ContactDaniel Webster
CorrespondentWilliam McLain
Keystone Regulatory Services, LLC 342 E. Main Street, Suite 207 Leola,  PA  17540
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-24
Decision Date2022-06-15

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