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FDA 510(k), K162579, VascuCel
FDA 510(k), K162579, VascuCel
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510(K) Number: K162579
Device Name: VascuCel
Manufacturer: Mary E. Donlin
Device Classification Name: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Regulation Number: DXZ
Classification Product Code: 09/15/2016
Date Received: 10/14/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: VascuCel
Manufacturer: Mary E. Donlin
Device Classification Name: Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Regulation Number: DXZ
Classification Product Code: 09/15/2016
Date Received: 10/14/2016
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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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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