The following data is part of a premarket notification filed by Certa Dose, Inc. with the FDA for Certa Dose Pd Epinephrine 1mg/ml Im/sc Syringe.
Device ID | K160589 |
510k Number | K160589 |
Device Name: | Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe |
Classification | Epinephrine Syringe |
Applicant | CERTA DOSE, INC. 573 RACE STREET Dever, CO 80206 |
Contact | Sarah Hanssen |
Correspondent | James A. Boiani EPSTEIN BECKER & GREEN, PC 1227 25TH ST NW, SUITE 700 Washington, DC 20037 |
Product Code | PQX |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-03-01 |
Decision Date | 2017-01-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860425001606 | K160589 | 000 |
00860012210800 | K160589 | 000 |