IR-192 IMPLANT -- MODIFICATION

Source, Brachytherapy, Radionuclide

OMNITRON INTL., INC.

The following data is part of a premarket notification filed by Omnitron Intl., Inc. with the FDA for Ir-192 Implant -- Modification.

Pre-market Notification Details

Device IDK923130
510k NumberK923130
Device Name:IR-192 IMPLANT -- MODIFICATION
ClassificationSource, Brachytherapy, Radionuclide
Applicant OMNITRON INTL., INC. P.O. BOX 5247 3409 WEST PRIE LAKE ROAD Lajke Charles,  LA  70606
Product CodeKXK  
CFR Regulation Number892.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-25
Decision Date1992-09-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.