IR-192 IMPLANT, MODIFICATION

Source, Wire, Iridium, Radioactive

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 IDK915253
510k NumberK915253
Device Name:IR-192 IMPLANT, MODIFICATION
ClassificationSource, Wire, Iridium, Radioactive
Applicant OMNITRON INTL., INC. P.O. BOX 5247 3409 WEST PRIE LAKE ROAD Lajke Charles,  LA  70606
ContactSam F Liprie
CorrespondentSam F Liprie
OMNITRON INTL., INC. P.O. BOX 5247 3409 WEST PRIE LAKE ROAD Lajke Charles,  LA  70606
Product CodeIWA  
CFR Regulation Number892.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-11-18
Decision Date1992-02-27

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