FDA 510(k) Application Details - K213800

Device Classification Name	More FDA Info for this Device
510(K) Number	K213800
Device Name	Artiglass NRFitTM Tip L.O.R. Glass Syringes
Applicant	Artiglass Srl Via Piemonte 13 Due Carrare 35020 IT Other 510(k) Applications for this Company
Contact	Sabrina Baccarin Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2021
Decision Date	05/19/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review