FDA 510(k) Application Details - K221981

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K221981
Device Name	Syringe, Antistick
Applicant	Roncadelle Operations srl Via Renolda 10 Castel Mella (Brescia) 25030 IT Other 510(k) Applications for this Company
Contact	Massimo Rossi Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	MEG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/05/2022
Decision Date	12/29/2022
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