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FDA 510(k), K071550, PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS
FDA 510(k), K071550, PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS
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510(K) Number: K071550
Device Name: PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS
Manufacturer: BETSY CORTELLONI
Device Classification Name: Source, Brachytherapy, Radionuclide
Regulation Number: KXK
Classification Product Code: 06/06/2007
Date Received: 07/18/2007
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS
Manufacturer: BETSY CORTELLONI
Device Classification Name: Source, Brachytherapy, Radionuclide
Regulation Number: KXK
Classification Product Code: 06/06/2007
Date Received: 07/18/2007
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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