FDA 510(k) Application Details - K242099

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K242099
Device Name	Syringe, Piston
Applicant	Sol-Millennium Medical Inc. 311 S Wacker Drive Suite 4100 Chicago, IL 60606 US Other 510(k) Applications for this Company
Contact	Kalia Manu Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	FMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2024
Decision Date	10/22/2024
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