FDA 510(k) Application Details - K230718

Device Classification Name	Accessories, Pump, Infusion   More FDA Info for this Device
510(K) Number	K230718
Device Name	Accessories, Pump, Infusion
Applicant	Gilero, LLC 635 Davis Drive Ste 100 Morrisville, NC 27560 US Other 510(k) Applications for this Company
Contact	Jessica Czamanski Other 510(k) Applications for this Contact
Regulation Number	880.5725   More FDA Info for this Regulation Number
Classification Product Code	MRZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/15/2023
Decision Date	06/15/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review