VHA Radiotherapy Bolus

Block, Beam-shaping, Radiation Therapy


The following data is part of a premarket notification filed by Vha Dean with the FDA for Vha Radiotherapy Bolus.

Pre-market Notification Details

Device IDK222639
510k NumberK222639
Device Name:VHA Radiotherapy Bolus
ClassificationBlock, Beam-shaping, Radiation Therapy
Applicant VHA DEAN 810 Vermont Ave NW Washington,  DC  20420
ContactBeth Ripley
CorrespondentLaura Gilmour
LG Strategies, LLC 3903 S. Congress Ave #3930 Austin,  TX  78704
Product CodeIXI  
CFR Regulation Number892.5710 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-01
Decision Date2022-11-04

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