FDA 510(k) Application Details - K212797

Device Classification Name	Pump, Infusion, Ophthalmic   More FDA Info for this Device
510(K) Number	K212797
Device Name	Pump, Infusion, Ophthalmic
Applicant	Glaukos 229 Avenida Fabricante San Clemente, CA 92672 US Other 510(k) Applications for this Company
Contact	Alex Bhaskarla Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MRH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/02/2021
Decision Date	01/06/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review