FDA 510(k) Application Details - K242956

Device Classification Name	More FDA Info for this Device
510(K) Number	K242956
Device Name	LDS Needle; OcuSafe« LDS Needle; SteriCap« LDS Safety Needle; VitreJect« LDS Safety Needle
Applicant	OcuJect, LLC 1441 Avocado Ave Suite 204 Newport Beach, CA 92660 US Other 510(k) Applications for this Company
Contact	Leonid Lerner Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QNS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2024
Decision Date	10/25/2024
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