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FDA 510(k), K050843, AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
FDA 510(k), K050843, AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
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510(K) Number: K050843
Device Name: AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
Manufacturer: Kathy O'Shaughnessy
Device Classification Name: System, Therapeutic, X-Ray
Regulation Number: JAD
Classification Product Code: 04/01/2005
Date Received: 12/22/2005
Decision Date: SE - With Limitations (SESU)
Regulation Medical Specialty: Radiology
Device Name: AXXENT ELECTRONIC BRACHYTHERAPY SYSTEM
Manufacturer: Kathy O'Shaughnessy
Device Classification Name: System, Therapeutic, X-Ray
Regulation Number: JAD
Classification Product Code: 04/01/2005
Date Received: 12/22/2005
Decision Date: SE - With Limitations (SESU)
Regulation Medical Specialty: Radiology
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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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