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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 K082921
Device Name RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
Applicant
Rad Source Technologies, Inc.
6825 Shiloh Rd. E.
Suite B2
Alpharetta,  GA  30005
Applicant Contact RANDOL E KIRK
Correspondent
Rad Source Technologies, Inc.
6825 Shiloh Rd. E.
Suite B2
Alpharetta,  GA  30005
Correspondent Contact RANDOL E KIRK
Classification Product Code
MOT  
Date Received10/01/2008
Decision Date 02/17/2009
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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