LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM

System, Applicator, Radionuclide, Remote-controlled

NUCLETRON B.V.

The following data is part of a premarket notification filed by Nucletron B.v. with the FDA for Luneray;catheter 6f 50cm, Needle 37mm R30mm/47mm R45mm/57mm R60mm/67mm R75 Mm.

Pre-market Notification Details

Device IDK140803
510k NumberK140803
Device Name:LUNERAY;CATHETER 6F 50CM, NEEDLE 37MM R30MM/47MM R45MM/57MM R60MM/67MM R75 MM
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant NUCLETRON B.V. WAARDGELDER 1 Veenendaal,  NL 3905 Th
ContactRudolf Vos
CorrespondentRudolf Vos
NUCLETRON B.V. WAARDGELDER 1 Veenendaal,  NL 3905 Th
Product CodeJAQ  
CFR Regulation Number892.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-31
Decision Date2014-06-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08717213054394 K140803 000
08717213054387 K140803 000
08717213054370 K140803 000
08717213054363 K140803 000

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