Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, Odd Lengths, Universal Cervix Probe Set, Even Lengths

System, Applicator, Radionuclide, Remote-controlled

Varian Medical Systems, Inc

The following data is part of a premarket notification filed by Varian Medical Systems, Inc with the FDA for Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, Odd Lengths, Universal Cervix Probe Set, Even Lengths.

Pre-market Notification Details

Device IDK160516
510k NumberK160516
Device Name:Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, Odd Lengths, Universal Cervix Probe Set, Even Lengths
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant Varian Medical Systems, Inc 911 Hansen Way Palo Alto,  CA  94304
ContactPeter J. Coronado
CorrespondentPeter J. Coronado
Varian Medical Systems, Inc 911 Hansen Way Palo Alto,  CA  94304
Product CodeJAQ  
CFR Regulation Number892.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-02-24
Decision Date2016-08-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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