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FDA 510(k), K131955, NEUROBLATE(TM) SYSTEM
FDA 510(k), K131955, NEUROBLATE(TM) SYSTEM
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510(K) Number: K131955
Device Name: NEUROBLATE(TM) SYSTEM
Manufacturer: MONTERIS MEDICAL, INC.
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 06/27/2013
Decision Date: 07/30/2013
Regulation Medical Specialty: General & Plastic Surgery
Device Name: NEUROBLATE(TM) SYSTEM
Manufacturer: MONTERIS MEDICAL, INC.
Device Classification Name: Powered Laser Surgical Instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 06/27/2013
Decision Date: 07/30/2013
Regulation Medical Specialty: General & Plastic Surgery
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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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