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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 St.
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
Predetermined Change
Control Plan Authorized		 No
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