APPLICATORS FOR AFTERLOADING BRACHYTHERAPY

System, Applicator, Radionuclide, Remote-controlled

ISODOSE CONTROL B.V.

The following data is part of a premarket notification filed by Isodose Control B.v. with the FDA for Applicators For Afterloading Brachytherapy.

Pre-market Notification Details

Device IDK082530
510k NumberK082530
Device Name:APPLICATORS FOR AFTERLOADING BRACHYTHERAPY
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant ISODOSE CONTROL B.V. MAXWELLSTRAAT 16 Ede,  NL 6716 Bx
ContactHub Van De Bergh
CorrespondentHub Van De Bergh
ISODOSE CONTROL B.V. MAXWELLSTRAAT 16 Ede,  NL 6716 Bx
Product CodeJAQ  
CFR Regulation Number892.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-02
Decision Date2008-10-30
Summary:summary

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