FDA 510(k) Application Details - K212805

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K212805
Device Name	Needle, Hypodermic, Single Lumen
Applicant	OcuJect, LLC 1441 Avocado Ave, Suite 204 Newport Beach, CA 92660 US Other 510(k) Applications for this Company
Contact	Rebecca K. Pine Other 510(k) Applications for this Contact
Regulation Number	880.5570   More FDA Info for this Regulation Number
Classification Product Code	FMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/02/2021
Decision Date	09/30/2021
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