OMNICATH IMPLANTED CATHETER AND DEPOT

Source, Brachytherapy, Radionuclide

OMNITRON INTL., INC.

The following data is part of a premarket notification filed by Omnitron Intl., Inc. with the FDA for Omnicath Implanted Catheter And Depot.

Pre-market Notification Details

Device IDK911775
510k NumberK911775
Device Name:OMNICATH IMPLANTED CATHETER AND DEPOT
ClassificationSource, Brachytherapy, Radionuclide
Applicant OMNITRON INTL., INC. 8990 KIRBY, SUITE 200 Houston,  TX  77054
ContactLisa S Jones
CorrespondentLisa S Jones
OMNITRON INTL., INC. 8990 KIRBY, SUITE 200 Houston,  TX  77054
Product CodeKXK  
CFR Regulation Number892.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-04-01
Decision Date1991-05-08

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