FDA 510(k) Application Details - K213088

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K213088
Device Name	Device, Anti-Snoring
Applicant	Sleeping Well, LLC 138 Steeplebush Rd. Shelburne, VT 05482 US Other 510(k) Applications for this Company
Contact	Daniel Webster Other 510(k) Applications for this Contact
Regulation Number	872.5570   More FDA Info for this Regulation Number
Classification Product Code	LRK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2021
Decision Date	06/15/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review