FDA 510(k) Application Details - K250459

Device Classification Name	Container, I.V.   More FDA Info for this Device
510(K) Number	K250459
Device Name	Container, I.V.
Applicant	Technoflex SAS. ZA de Bassilour Bidart 64210 FR Other 510(k) Applications for this Company
Contact	Dominique Saint Ellier 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	02/18/2025
Decision Date	04/18/2025
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