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 |