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FDA 510(k), K193375, NeuroBlate System
FDA 510(k), K193375, NeuroBlate System
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$149.00 USD
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$149.00 USD
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510(K) Number: K193375
Device Name: NeuroBlate System
Manufacturer: David H. Mueller
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: GEX
Classification Product Code: 12/05/2019
Date Received: 01/03/2020
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Neurology
Device Name: NeuroBlate System
Manufacturer: David H. Mueller
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: GEX
Classification Product Code: 12/05/2019
Date Received: 01/03/2020
Decision Date: Substantially Equivalent (SESE)
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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