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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Irradiator, Blood To Prevent Graft Versus Host Disease
510(k) Number K201177
Device Name RadGil2
Applicant
R3 X-Ray L.L.C
2730 E. Broadway BLVD STE 160
Tucson,  AZ  85716
Applicant Contact Robert Hase
Correspondent
R3 X-Ray L.L.C
2730 E. Broadway BLVD STE 160
Tucson,  AZ  85716
Correspondent Contact Robert Hase
Classification Product Code
MOT  
Date Received05/01/2020
Decision Date 08/17/2020
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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