OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR

System, Applicator, Radionuclide, Remote-controlled

OMNITRON INTL., INC.

The following data is part of a premarket notification filed by Omnitron Intl., Inc. with the FDA for Omnitron Remote Controlled Radionuclide Applicator.

Pre-market Notification Details

Device IDK881665
510k NumberK881665
Device Name:OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant OMNITRON INTL., INC. 3839 ULLOA ST. SUITE 100 New Orleans,  LA  70119
ContactKathleen W Judge
CorrespondentKathleen W Judge
OMNITRON INTL., INC. 3839 ULLOA ST. SUITE 100 New Orleans,  LA  70119
Product CodeJAQ  
CFR Regulation Number892.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-04-18
Decision Date1988-08-11

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