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FDA 510(k), K060679, SURTRAK IMPLANTATION KIT
FDA 510(k), K060679, SURTRAK IMPLANTATION KIT
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510(K) Number: K060679
Device Name: SURTRAK IMPLANTATION KIT
Manufacturer: LEIGH SPOTTEN
Device Classification Name: Source, Brachytherapy, Radionuclide
Regulation Number: KXK
Classification Product Code: 03/15/2006
Date Received: 04/21/2006
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: SURTRAK IMPLANTATION KIT
Manufacturer: LEIGH SPOTTEN
Device Classification Name: Source, Brachytherapy, Radionuclide
Regulation Number: KXK
Classification Product Code: 03/15/2006
Date Received: 04/21/2006
Decision Date: Substantially Equivalent (SESE)
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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