FDA 510(k), K143457, NeuroBlate System
FDA 510(k), K143457, NeuroBlate System
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510(K) Number: K143457
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: 12/03/2014
Decision Date: 02/19/2015
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: 12/03/2014
Decision Date: 02/19/2015
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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