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FDA 510(k), K121195, NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
FDA 510(k), K121195, NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
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510(K) Number: K121195
Device Name: NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
Manufacturer: NINEPOINT MEDICAL, INC
Device Classification Name: system, imaging, optical coherence tomography (oct)
Regulation Number: 892.1560
Classification Product Code: NQQ
Date Received: 04/19/2012
Decision Date: 07/25/2012
Regulation Medical Specialty: Radiology
Device Name: NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
Manufacturer: NINEPOINT MEDICAL, INC
Device Classification Name: system, imaging, optical coherence tomography (oct)
Regulation Number: 892.1560
Classification Product Code: NQQ
Date Received: 04/19/2012
Decision Date: 07/25/2012
Regulation Medical Specialty: Radiology
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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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