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FDA 510(k), K161893, Neuromonitoring Kit
FDA 510(k), K161893, Neuromonitoring Kit
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510(K) Number: K161893
Device Name: Neuromonitoring Kit
Manufacturer: ROXANNE DUBOIS
Device Classification Name: Neurosurgical Nerve Locator
Regulation Number: PDQ
Classification Product Code: KXA
Date Received: 07/11/2016
Decision Date: 10/18/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: Neuromonitoring Kit
Manufacturer: ROXANNE DUBOIS
Device Classification Name: Neurosurgical Nerve Locator
Regulation Number: PDQ
Classification Product Code: KXA
Date Received: 07/11/2016
Decision Date: 10/18/2016
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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