SMIT SLEEVE

System, Applicator, Radionuclide, Remote-controlled

NUCLETRON CORPORATION

The following data is part of a premarket notification filed by Nucletron Corporation with the FDA for Smit Sleeve.

Pre-market Notification Details

Device IDK052228
510k NumberK052228
Device Name:SMIT SLEEVE
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant NUCLETRON CORPORATION 8671 ROBERT FULTON DR. Columbia,  MD  21046 -2133
ContactLisa Dimmick
CorrespondentJ.a. Van Vugt
KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont,  PA  18914
Product CodeJAQ  
CFR Regulation Number892.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2005-08-16
Decision Date2005-11-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08717213057258 K052228 000
08717213057203 K052228 000

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