VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS

System, Applicator, Radionuclide, Remote-controlled

VARIAN MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Varian Medical Systems with the FDA for Varian Intracavitary Brachytherapy Applicators.

Pre-market Notification Details

Device IDK033371
510k NumberK033371
Device Name:VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant VARIAN MEDICAL SYSTEMS 3100 HANSEN WAY M/S E-110 Palo Alto,  CA  94304 -1129
ContactVy Tran
CorrespondentVy Tran
VARIAN MEDICAL SYSTEMS 3100 HANSEN WAY M/S E-110 Palo Alto,  CA  94304 -1129
Product CodeJAQ  
CFR Regulation Number892.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-10-21
Decision Date2003-12-24
Summary:summary

NIH GUDID Devices

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