FDA 510(k), K053610, ABARIS
FDA 510(k), K053610, ABARIS
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510(K) Number: K053610
Device Name: ABARIS
Manufacturer: TRAXTAL TECHNOLOGIES INC.
Device Classification Name: system, x-ray, tomography, computed
Regulation Number: 892.1750
Classification Product Code: JAK
Date Received: 12/27/2005
Decision Date: 04/19/2006
Regulation Medical Specialty: Radiology
Device Name: ABARIS
Manufacturer: TRAXTAL TECHNOLOGIES INC.
Device Classification Name: system, x-ray, tomography, computed
Regulation Number: 892.1750
Classification Product Code: JAK
Date Received: 12/27/2005
Decision Date: 04/19/2006
Regulation Medical Specialty: Radiology
- 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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