FDA 510(k) Application Details - K181107

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K181107
Device Name	Device, Anti-Snoring
Applicant	Zelegent, Inc. 5151 California Avenue Irvine, CA 92617 US Other 510(k) Applications for this Company
Contact	David C. Humbert 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	04/26/2018
Decision Date	12/06/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	EN - Ear, Nose, & Throat
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review