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FDA 510(k), K192955, Penumbra LP Coil System
FDA 510(k), K192955, Penumbra LP Coil System
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510(K) Number: K192955
Device Name: Penumbra LP Coil System
Manufacturer: Penumbra, Inc.
Device Classification Name: Device, Neurovascular Embolization
Regulation Number: 882.5950
Classification Product Code: HCG
Date Received: 10/21/2019
Decision Date: 11/20/2019
Regulation Medical Specialty: Neurology
Device Name: Penumbra LP Coil System
Manufacturer: Penumbra, Inc.
Device Classification Name: Device, Neurovascular Embolization
Regulation Number: 882.5950
Classification Product Code: HCG
Date Received: 10/21/2019
Decision Date: 11/20/2019
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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