FDA 510(k) Application Details - DEN230061

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN230061
Device Name	allay Nerve Cap
Applicant	Tulavi Therapeutics 160 Knowles Ave Los Gatos, CA 95032 US Other 510(k) Applications for this Company
Contact	Corinne Bright Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SBG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2023
Decision Date	07/16/2024
Decision	DENG -
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review