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FDA 510(k), K162176, Fiagon Navigation System
FDA 510(k), K162176, Fiagon Navigation System
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510(K) Number: K162176
Device Name: Fiagon Navigation System
Manufacturer: Fiagon GmbH
Device Classification Name: ear, nose, and throat stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: PGW
Date Received: 08/03/2016
Decision Date: 12/01/2016
Regulation Medical Specialty: Neurology
Device Name: Fiagon Navigation System
Manufacturer: Fiagon GmbH
Device Classification Name: ear, nose, and throat stereotaxic instrument
Regulation Number: 882.4560
Classification Product Code: PGW
Date Received: 08/03/2016
Decision Date: 12/01/2016
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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