Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source

Source, Brachytherapy, Radionuclide

SOURCE PRODUCTION AND EQUIPMENT CO., INC.

The following data is part of a premarket notification filed by Source Production And Equipment Co., Inc. with the FDA for Source Production & Equipment Co., Inc. Model M14 192iridium Brachytherapy Source.

Pre-market Notification Details

Device IDK162573
510k NumberK162573
Device Name:Source Production & Equipment Co., Inc. Model M14 192Iridium Brachytherapy Source
ClassificationSource, Brachytherapy, Radionuclide
Applicant SOURCE PRODUCTION AND EQUIPMENT CO., INC. 113 TEAL STREET Saint Rose,  LA  70087
ContactKelley Richardt
CorrespondentKelley Richardt
SOURCE PRODUCTION AND EQUIPMENT CO., INC. 113 TEAL STREET Saint Rose,  LA  70087
Product CodeKXK  
CFR Regulation Number892.5730 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-09-15
Decision Date2016-11-04
Summary:summary

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