FDA 510(k) Application Details - K160589

Device Classification Name	More FDA Info for this Device
510(K) Number	K160589
Device Name	Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe
Applicant	CERTA DOSE, INC. 573 RACE STREET DEVER, CO 80206 US Other 510(k) Applications for this Company
Contact	SARAH HANSSEN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/01/2016
Decision Date	01/19/2017
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