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510(k) K082921

RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 by Rad Source Technologies, Inc. — Product Code MOT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2009
Date Received
October 1, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Irradiator, Blood To Prevent Graft Versus Host Disease
Device Class
Class U
Regulation Number
Review Panel
RA
Submission Type

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  • K963497 — GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0 (November 8, 1996)
  • K952291 — GAMMACELL 3000 ELAN (August 25, 1995)