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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 K172087
Device Name SANGRAY
Applicant
Hitachi , Ltd.
2-1, Shintoyofuta
Kashiwa-Shi,  JP 277-0804
Applicant Contact Kazuaki Tsuchiya
Correspondent
Globizz Corporation
1411 W. 190th St., Suite #200
Gardena,  CA  90248
Correspondent Contact Takahiro Haruyama
Classification Product Code
MOT  
Date Received07/11/2017
Decision Date 10/27/2017
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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