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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 K181737
Device Name Raycell MK1
Applicant
Best Theratronics Limited
413 March Rd.
Ottawa,  CA k2k 0e4
Applicant Contact Mojgan Soleimani
Correspondent
Best Theratronics Limited
413 March Rd.
Ottawa,  CA k2k 0e4
Correspondent Contact Mojgan Soleimani
Classification Product Code
MOT  
Date Received07/02/2018
Decision Date 01/02/2019
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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