MEDRAD STELLANT CT INJECTOR SYSTEM

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.

Pre-market Notification Details

Device IDK023183
510k NumberK023183
Device Name:MEDRAD STELLANT CT INJECTOR SYSTEM
ClassificationInjector And Syringe, Angiographic
Applicant MEDRAD, INC. ONE MEDRAD DR. Indianola,  PA  15051
ContactFrank W Pelc Iii
CorrespondentFrank W Pelc Iii
MEDRAD, INC. ONE MEDRAD DR. Indianola,  PA  15051
Product CodeDXT  
CFR Regulation Number870.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-09-24
Decision Date2003-01-10
Summary:summary

NIH GUDID Devices

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