FDA 510(k) Application Details - K251585

Device Classification Name	More FDA Info for this Device
510(K) Number	K251585
Device Name	ProfojectÖ Enteral Feeding Syringe
Applicant	CMT Health PTE. Ltd. 150 Beach Road, #28-05, Gateway West Singapore 189720 SG Other 510(k) Applications for this Company
Contact	Monica Ma 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	05/23/2025
Decision Date	07/18/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review