SMART-ROD

Set, I.v. Fluid Transfer

DUOJECT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Duoject Medical Systems, Inc. with the FDA for Smart-rod.

Pre-market Notification Details

Device IDK070584
510k NumberK070584
Device Name:SMART-ROD
ClassificationSet, I.v. Fluid Transfer
Applicant DUOJECT MEDICAL SYSTEMS, INC. 50 CHEMIN DE GASPE COMPLEX B-5 Bromont,  CA J2l 2n8
ContactCaroline Lavoie
CorrespondentCaroline Lavoie
DUOJECT MEDICAL SYSTEMS, INC. 50 CHEMIN DE GASPE COMPLEX B-5 Bromont,  CA J2l 2n8
Product CodeLHI  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-01
Decision Date2008-04-02
Summary:summary

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