MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE

Injector And Syringe, Angiographic

MEDRAD, INC.

The following data is part of a premarket notification filed by Medrad, Inc. with the FDA for Medrad Stellant Ct Injector System With Imaging System Interface Module.

Pre-market Notification Details

Device IDK033881
510k NumberK033881
Device Name:MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE
ClassificationInjector And Syringe, Angiographic
Applicant MEDRAD, INC. ONE MEDRAD DR. Indianola,  PA  15051
ContactTroy A Jack
CorrespondentTroy A Jack
MEDRAD, INC. ONE MEDRAD DR. Indianola,  PA  15051
Product CodeDXT  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-12-15
Decision Date2004-03-02
Summary:summary

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