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FDA 510(k), K092405, MAMMOSITE MULTI LUMEN
FDA 510(k), K092405, MAMMOSITE MULTI LUMEN
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510(K) Number: K092405
Device Name: MAMMOSITE MULTI LUMEN
Manufacturer: JENNIFER SULLIVAN
Device Classification Name: System, Applicator, Radionuclide, Remote-Controlled
Regulation Number: JAQ
Classification Product Code: 08/06/2009
Date Received: 08/27/2009
Decision Date: SE - With Limitations (SESU)
Regulation Medical Specialty: Radiology
Device Name: MAMMOSITE MULTI LUMEN
Manufacturer: JENNIFER SULLIVAN
Device Classification Name: System, Applicator, Radionuclide, Remote-Controlled
Regulation Number: JAQ
Classification Product Code: 08/06/2009
Date Received: 08/27/2009
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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