RadGil2

Irradiator, Blood To Prevent Graft Versus Host Disease

R3 X-Ray L.L.C

The following data is part of a premarket notification filed by R3 X-ray L.l.c with the FDA for Radgil2.

Pre-market Notification Details

Device IDK201177
510k NumberK201177
Device Name:RadGil2
ClassificationIrradiator, Blood To Prevent Graft Versus Host Disease
Applicant R3 X-Ray L.L.C 2730 E. Broadway BLVD STE 160 Tucson,  AZ  85716
ContactRobert Hase
CorrespondentRobert Hase
R3 X-Ray L.L.C 2730 E. Broadway BLVD STE 160 Tucson,  AZ  85716
Product CodeMOT  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-01
Decision Date2020-08-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B850033600040 K201177 000

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