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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 K161324
Device Name Raycell Mk2
Applicant
Best Theratronics Limited
413 March Rd.
Ottawa,  CA k2k 0e4
Applicant Contact MIKE DE VAN DER SCHUEREN
Correspondent
Best Theratronics Limited
413 March Rd.
Ottawa,  CA k2k 0e4
Correspondent Contact MIKE DE VAN DER SCHUEREN
Classification Product Code
MOT  
Date Received05/11/2016
Decision Date 08/12/2016
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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