FDA 510(k) Application Details - K200416

Device Classification Name	Products, Contact Lens Care, Rigid Gas Permeable   More FDA Info for this Device
510(K) Number	K200416
Device Name	Products, Contact Lens Care, Rigid Gas Permeable
Applicant	Bausch & Lomb Incorporated 400 Somerset Corporate Boulevard Bridgewater, NJ 08807 US Other 510(k) Applications for this Company
Contact	Pinal Shah 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	02/20/2020
Decision Date	09/23/2020
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