FDA 510(k) Application Details - K193589

Device Classification Name	More FDA Info for this Device
510(K) Number	K193589
Device Name	TrueTear Intranasal Tear Neurostimulator
Applicant	Allergan 2525 Dupont Drive Irvine, CA 92612 US Other 510(k) Applications for this Company
Contact	Barbara Simon 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	12/23/2019
Decision Date	08/31/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review