FDA 510(k) Application Details - K201484

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K201484
Device Name	Device, Anti-Snoring
Applicant	Koncept Innovators, LLC. 1619 Executive Ave Myrtle Beach, SC 29577 US Other 510(k) Applications for this Company
Contact	Sylvan Newby 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	06/04/2020
Decision Date	11/23/2020
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