Device Classification Name |
epinephrine syringe
|
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
|
|
Applicant Contact |
SARAH HANSSEN |
Correspondent |
EPSTEIN BECKER & GREEN, PC |
1227 25TH ST NW, SUITE 700 |
WASHINGTON,
DC
20037
|
|
Correspondent Contact |
JAMES A. BOIANI |
Regulation Number | 880.5860
|
Classification Product Code |
|
Date Received | 03/01/2016 |
Decision Date | 01/19/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|