FDA 510(k) Application Details - K211786

Device Classification Name	Media, Corneal Storage   More FDA Info for this Device
510(K) Number	K211786
Device Name	Media, Corneal Storage
Applicant	Bausch + Lomb, Incorporated 3365 Tree Court Industrial Boulevard St. Louis, MO 63122 US Other 510(k) Applications for this Company
Contact	Heather Christie Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LYX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/09/2021
Decision Date	12/03/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review