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FDA 510(k), K190887, Leksell Vantage Stereotactic System
FDA 510(k), K190887, Leksell Vantage Stereotactic System
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510(K) Number: K190887
Device Name: Leksell Vantage Stereotactic System
Manufacturer: Elekta Instrument AB
Device Classification Name: Neurological Stereotaxic Instrument
Regulation Number: 882.4560
Classification Product Code: HAW
Date Received: 04/04/2019
Decision Date: 08/01/2019
Regulation Medical Specialty: Neurology
Device Name: Leksell Vantage Stereotactic System
Manufacturer: Elekta Instrument AB
Device Classification Name: Neurological Stereotaxic Instrument
Regulation Number: 882.4560
Classification Product Code: HAW
Date Received: 04/04/2019
Decision Date: 08/01/2019
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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