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FDA 510(k), K162762, NeuroBlate System
FDA 510(k), K162762, NeuroBlate System
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$49.00 USD
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510(K) Number: K162762
Device Name: NeuroBlate System
Manufacturer: Monteris Medical, Inc.
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 09/30/2016
Decision Date: 10/26/2016
Regulation Medical Specialty: General & Plastic Surgery
Device Name: NeuroBlate System
Manufacturer: Monteris Medical, Inc.
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 09/30/2016
Decision Date: 10/26/2016
Regulation Medical Specialty: General & Plastic Surgery
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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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