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FDA 510(k), K103305, PENUMBRA EMBOLIZATION COIL SYSTEM
FDA 510(k), K103305, PENUMBRA EMBOLIZATION COIL SYSTEM
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510(K) Number: K103305
Device Name: PENUMBRA EMBOLIZATION COIL SYSTEM
Manufacturer: PENUMBRA, INC.
Device Classification Name: Device, Neurovascular Embolization
Regulation Number: 882.5950
Classification Product Code: HCG
Date Received: 11/09/2010
Decision Date: 01/26/2011
Regulation Medical Specialty: Neurology
Device Name: PENUMBRA EMBOLIZATION COIL SYSTEM
Manufacturer: PENUMBRA, INC.
Device Classification Name: Device, Neurovascular Embolization
Regulation Number: 882.5950
Classification Product Code: HCG
Date Received: 11/09/2010
Decision Date: 01/26/2011
Regulation Medical Specialty: Neurology
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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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