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FDA 510(k), K160045, Heyman Packing Applicator Set
FDA 510(k), K160045, Heyman Packing Applicator Set
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510(K) Number: K160045
Device Name: Heyman Packing Applicator Set
Manufacturer: PETER J. CORONADO
Device Classification Name: System, Applicator, Radionuclide, Remote-Controlled
Regulation Number: JAQ
Classification Product Code: 01/08/2016
Date Received: 11/17/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: Heyman Packing Applicator Set
Manufacturer: PETER J. CORONADO
Device Classification Name: System, Applicator, Radionuclide, Remote-Controlled
Regulation Number: JAQ
Classification Product Code: 01/08/2016
Date Received: 11/17/2016
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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