CONTRAST CONTROL DEVICE

Set, Administration, Intravascular

MEDEX, INC.

The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Contrast Control Device.

Pre-market Notification Details

Device IDK982123
510k NumberK982123
Device Name:CONTRAST CONTROL DEVICE
ClassificationSet, Administration, Intravascular
Applicant MEDEX, INC. 3637 LACON RD. Hilliard,  OH  43026
ContactCindy Chenetski
CorrespondentCindy Chenetski
MEDEX, INC. 3637 LACON RD. Hilliard,  OH  43026
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-06-16
Decision Date1998-07-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20886333208887 K982123 000
40889942856009 K982123 000

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