FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 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 Fletcher Ct/mr Shielded Applicator Set (6 Mm) Fletcher Ct/mr Shielded Applicator Set (4 Mm).

Pre-market Notification Details

Device IDK132889
510k NumberK132889
Device Name:FLETCHER CT/MR SHIELDED APPLICATOR SET (6 MM) FLETCHER CT/MR SHIELDED APPLICATOR SET (4 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 Received2013-09-16
Decision Date2014-02-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08717213024441 K132889 000
08717213024298 K132889 000
08717213014121 K132889 000
08717213024342 K132889 000

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