FDA 510(k) Application Details - DEN140022

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN140022
Device Name	GLAUCOMA COMPANION
Applicant	INNOVATEX, INC. 150 BUCKSKIN DR. WESTON, MA 02493 US Other 510(k) Applications for this Company
Contact	STEPHEN C CHEN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2014
Decision Date	04/20/2016
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