Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe

Epinephrine Syringe

CERTA DOSE, INC.

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.

Pre-market Notification Details

Device IDK160589
510k NumberK160589
Device Name:Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe
ClassificationEpinephrine Syringe
Applicant CERTA DOSE, INC. 573 RACE STREET Dever,  CO  80206
ContactSarah Hanssen
CorrespondentJames A. Boiani
EPSTEIN BECKER & GREEN, PC 1227 25TH ST NW, SUITE 700 Washington,  DC  20037
Product CodePQX  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-01
Decision Date2017-01-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860425001606 K160589 000
00860012210800 K160589 000

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