FDA 510(k) Application Details - DEN190026

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN190026
Device Name	iTEAR Neurostimulator
Applicant	Olympic Ophthalmics, Inc. 400 NW Gilman Blvd. #1370 Issaquah, WA 98027 US Other 510(k) Applications for this Company
Contact	Michael Gertner Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QKV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/15/2019
Decision Date	05/01/2020
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