FDA 510(k) Application Details - K243652

Device Classification Name	More FDA Info for this Device
510(K) Number	K243652
Device Name	MonojectÖ Enteral Syringe with ENFit Connector (401SE); MonojectÖ Enteral Syringe with ENFit Connector (403SE); MonojectÖ Enteral Syringe with ENFit Connector (406SE); MonojectÖ Enteral Syringe with ENFit Connector (412SE); MonojectÖ Enteral Syringe with
Applicant	Cardinal Health 3651 Birchwood Dr. Waukegan, IL 60085 US Other 510(k) Applications for this Company
Contact	Kathleen Di Leo Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/26/2024
Decision Date	12/19/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review