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FDA 510(k), K974210, SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000
FDA 510(k), K974210, SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000
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510(K) Number: K974210
Device Name: SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000
Manufacturer: RAD-SOURCE, INC.
Device Classification Name: irradiator, blood to prevent graft versus host disease
Regulation Number:
Classification Product Code: MOT
Date Received: 11/10/1997
Decision Date: 03/30/1998
Regulation Medical Specialty:
Device Name: SHIELDED CABINET X-RAY RADIATION SOURCE DEVICE MODEL RS 3000
Manufacturer: RAD-SOURCE, INC.
Device Classification Name: irradiator, blood to prevent graft versus host disease
Regulation Number:
Classification Product Code: MOT
Date Received: 11/10/1997
Decision Date: 03/30/1998
Regulation Medical Specialty:
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- 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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