FDA 510(k) Application Details - DEN170086

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN170086
Device Name	TrueTear Intranasal Tear Neurostimulator
Applicant	Allergan 2525 Dupont Drive Irvine, CA 92612 US Other 510(k) Applications for this Company
Contact	Nooshin Azizi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QBR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/23/2017
Decision Date	05/17/2018
Decision	DENG -
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review