Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe— 510(k) K160589

Name: FDA 510(k) clearance K160589
Creator: U.S. Food and Drug Administration
Published: 2017-01-19

Substantially Equivalent

Certa Dose, Inc.

FDA 510(k) clearance K160589 for Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe, Substantially Equivalent on 2017-01-19. Applicant: Certa Dose, Inc.. Device class: 2.

Clearance details

Applicant: Certa Dose, Inc.
Product code: Code PQX
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2016-03-01
Decision date: 2017-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dever, CO, US

Download summary PDF View on FDA.gov ↗

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