FDA 510(k) Application Details - K201936

Device Classification Name	Container, I.V.   More FDA Info for this Device
510(K) Number	K201936
Device Name	Container, I.V.
Applicant	Gilero, LLC 635 Davis Drive, Suite 100 Morrisville, NC 27560 US Other 510(k) Applications for this Company
Contact	Kristin Benokraitis Other 510(k) Applications for this Contact
Regulation Number	880.5025   More FDA Info for this Regulation Number
Classification Product Code	KPE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/13/2020
Decision Date	05/06/2021
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	Y
Expedited Review