FDA 510(k) Application Details - K242434

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K242434
Device Name	Syringe, Piston
Applicant	CHIRANA T. Injecta Nßm. Dr. Schweitzera 194 Starß Turß 91601 SK Other 510(k) Applications for this Company
Contact	Rastislav Broska 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	08/16/2024
Decision Date	12/24/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review