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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name epinephrine syringe
510(k) Number K160589
Device Name Certa Dose PD Epinephrine 1mg/mL IM/SC Syringe
Applicant
CERTA DOSE, INC.
573 RACE STREET
dever,  CO  80206
Applicant Contact sarah hanssen
Correspondent
EPSTEIN BECKER & GREEN, PC
1227 25TH ST NW, SUITE 700
washington,  DC  20037
Correspondent Contact james a. boiani
Regulation Number880.5860
Classification Product Code
PQX  
Date Received03/01/2016
Decision Date 01/19/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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