FDA 510(k) Application Details - K201069

Device Classification Name	Products, Contact Lens Care, Rigid Gas Permeable   More FDA Info for this Device
510(K) Number	K201069
Device Name	Products, Contact Lens Care, Rigid Gas Permeable
Applicant	Dry Eye Innovations, LLC 1200 Harger Rd. Suite 211 Oak Brook, IL 60523 US Other 510(k) Applications for this Company
Contact	Donald R. Sanders Other 510(k) Applications for this Contact
Regulation Number	886.5918   More FDA Info for this Regulation Number
Classification Product Code	MRC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2020
Decision Date	07/31/2020
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