FDA 510(k) Application Details - K213173

Device Classification Name	Pump, Infusion, Ophthalmic   More FDA Info for this Device
510(K) Number	K213173
Device Name	Pump, Infusion, Ophthalmic
Applicant	MicroSurgical Technologies Inc 8415 154th Ave NE Redmond, WA 98052 US Other 510(k) Applications for this Company
Contact	Angela Mallery 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	09/28/2021
Decision Date	06/08/2022
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