510(k) K160589
- Device
- Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe
- Applicant
- CERTA DOSE, INC.
- 510(k) number
- K160589
- Product code
- PQX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-01-19
- Date received
- 2016-03-01
- Regulation
- 880.5860
- Classification name
- Epinephrine Syringe
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SARAH HANSSEN
- Address
- 573 Race St. Dever CO US 80206 80206
FDA Registration Numbers#
- 1225580
- 1220477
- 3020460367
- 3014759854
Source Documents#
Other 510(k) Records For Product Code PQX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K180683 | Certa Dose Pediatric Midazolam 5mg/mL IM Syringe | Certa Dose, Inc. | 2018-11-07 |
Legacy Summary#
summary
FDA Review#
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