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FDA 510(k), K153479, NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System
FDA 510(k), K153479, NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System
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510(K) Number: K153479
Device Name: NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System
Manufacturer: NINEPOINT MEDICAL, INC
Device Classification Name: system, imaging, optical coherence tomography (oct)
Regulation Number: 892.1560
Classification Product Code: NQQ
Date Received: 12/02/2015
Decision Date: 02/16/2016
Regulation Medical Specialty: Radiology
Device Name: NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System
Manufacturer: NINEPOINT MEDICAL, INC
Device Classification Name: system, imaging, optical coherence tomography (oct)
Regulation Number: 892.1560
Classification Product Code: NQQ
Date Received: 12/02/2015
Decision Date: 02/16/2016
Regulation Medical Specialty: Radiology
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