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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 K121195
Models 91101, 92101
Device Name NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
Original Applicant
NINEPOINT MEDICAL, INC
1171 barroihet avenue
hillsborough,  CA  94010
Original Contact cindy domecus
Regulation Number892.1560
Classification Product Code
NQQ  
Date Received04/19/2012
Decision Date 07/25/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee General & Plastic Surgery
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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