FDA 510(k) Application Details - DEN160030

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN160030
Device Name	Oculeve Intranasal Tear Neurostimulator Device
Applicant	OCULEVE, INC. 395 OYSTER POINT BLVD SUITE 501 SOUTH SAN FRANCISCO, CA 94080 US Other 510(k) Applications for this Company
Contact	ANDY DORAISWAMY Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/07/2016
Decision Date	04/24/2017
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