FDA 510(k) Application Details - K214080

Device Classification Name	Saline, Vascular Access Flush   More FDA Info for this Device
510(K) Number	K214080
Device Name	Saline, Vascular Access Flush
Applicant	PENTAFERTE ITALIA S.R.L. Viale Piane Nocella, 23 Campli Teramo 64012 IT Other 510(k) Applications for this Company
Contact	Rosa Di Gioia Other 510(k) Applications for this Contact
Regulation Number	880.5200   More FDA Info for this Regulation Number
Classification Product Code	NGT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/2021
Decision Date	07/20/2022
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