FDA 510(k) Application Details - K243232

Device Classification Name	Introducer, Syringe Needle   More FDA Info for this Device
510(K) Number	K243232
Device Name	Introducer, Syringe Needle
Applicant	Synthon Hispania S.L. Calle Castello, 1 Poligono Las Salinas Sant Boi de Llobregat 08830 ES Other 510(k) Applications for this Company
Contact	Ana Miralles Other 510(k) Applications for this Contact
Regulation Number	880.6920   More FDA Info for this Regulation Number
Classification Product Code	KZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/2024
Decision Date	12/02/2024
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