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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Optical Coherence Tomography (Oct)
510(k) Number K143678
Device Name NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory
Applicant
NINEPOINT MEDICAL, INC.
ONE KENDALL SQUARE, SUITE B7501
CAMBRIDGE,  MA  02139
Applicant Contact SCOTT BLOOD
Correspondent
NINEPOINT MEDICAL, INC.
ONE KENDALL SQUARE, SUITE B7501
CAMBRIDGE,  MA  02139
Correspondent Contact SCOTT BLOOD
Regulation Number892.1560
Classification Product Code
NQQ  
Date Received12/24/2014
Decision Date 02/06/2015
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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