FDA 510(k) Application Details - K193528

Device Classification Name	Container, I.V.   More FDA Info for this Device
510(K) Number	K193528
Device Name	Container, I.V.
Applicant	Haemotronic, Spa 16, Via Carreri Mirandola 41037 IT Other 510(k) Applications for this Company
Contact	Paola Franciosi 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	12/19/2019
Decision Date	07/22/2020
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