The following data is part of a premarket notification filed by Certa Dose, Inc. with the FDA for Certa Dose Pediatric Midazolam 5mg/ml Im Syringe.
| Device ID | K180683 |
| 510k Number | K180683 |
| Device Name: | Certa Dose Pediatric Midazolam 5mg/mL IM Syringe |
| Classification | Epinephrine Syringe |
| Applicant | Certa Dose, Inc. 7351 E Lowry Blvd. #400 Denver, CO 80230 |
| Contact | Caleb Hernandez |
| Correspondent | James A. Boiani Epstein Becker & Green, P.C. 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 | Yes |
| Date Received | 2018-03-15 |
| Decision Date | 2018-11-07 |
| Summary: | summary |