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FDA 510(k), K180854, Voyager Trajectory Array Guide (V-TAG)
FDA 510(k), K180854, Voyager Trajectory Array Guide (V-TAG)
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$49.00 USD
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510(K) Number: K180854
Device Name: Voyager Trajectory Array Guide (V-TAG)
Manufacturer: Lynn E Bayless
Device Classification Name: Neurological Stereotaxic Instrument
Regulation Number: HAW
Classification Product Code: KXA
Date Received: 04/02/2018
Decision Date: 07/23/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: Voyager Trajectory Array Guide (V-TAG)
Manufacturer: Lynn E Bayless
Device Classification Name: Neurological Stereotaxic Instrument
Regulation Number: HAW
Classification Product Code: KXA
Date Received: 04/02/2018
Decision Date: 07/23/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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