Geneva

System, Applicator, Radionuclide, Remote-controlled

Nucletron BV

The following data is part of a premarket notification filed by Nucletron Bv with the FDA for Geneva.

Pre-market Notification Details

Device IDK201272
510k NumberK201272
Device Name:Geneva
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant Nucletron BV Waardgelder 1 Veenendaal,  NL 3905th
ContactRigo Meens
CorrespondentRigo Meens
Nucletron BV Waardgelder 1 Veenendaal,  NL 3905th
Product CodeJAQ  
CFR Regulation Number892.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-12
Decision Date2020-07-16

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