FDA 510(k), K082921, RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
FDA 510(k), K082921, RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
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510(K) Number: K082921
Device Name: RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
Manufacturer: RAD SOURCE TECHNOLOGIES, INC.
Device Classification Name: irradiator, blood to prevent graft versus host disease
Regulation Number:
Classification Product Code: MOT
Date Received: 10/01/2008
Decision Date: 02/17/2009
Regulation Medical Specialty:
Device Name: RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
Manufacturer: RAD SOURCE TECHNOLOGIES, INC.
Device Classification Name: irradiator, blood to prevent graft versus host disease
Regulation Number:
Classification Product Code: MOT
Date Received: 10/01/2008
Decision Date: 02/17/2009
Regulation Medical Specialty:
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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