FDA 510(k), K172881, NeuroBlate System
FDA 510(k), K172881, NeuroBlate System
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510(K) Number: K172881
Device Name: NeuroBlate System
Manufacturer: Monteris Medical
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 09/21/2017
Decision Date: 10/20/2017
Regulation Medical Specialty: General & Plastic Surgery
Device Name: NeuroBlate System
Manufacturer: Monteris Medical
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 09/21/2017
Decision Date: 10/20/2017
Regulation Medical Specialty: General & Plastic Surgery
- 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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