FDA 510(k) Application Details - K232943

Device Classification Name	More FDA Info for this Device
510(K) Number	K232943
Device Name	Hypodermic Needle-Pro« EDGEÖ Safety Device with Low Dead Space Syringe
Applicant	Smiths Medical ASD Inc 6000 Nathan Lane N Plymouth, MN 55442 US Other 510(k) Applications for this Company
Contact	Ben Rappaport Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/2023
Decision Date	05/31/2024
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