SPEC Model M23

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 Spec Model M23.

Pre-market Notification Details

Device IDK161396
510k NumberK161396
Device Name:SPEC Model M23
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 Received2016-05-19
Decision Date2016-08-17
Summary:summary

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