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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 K120800
Model 91101, 92101
Device Name NVISION VLE IMAGING SYSTEM
Applicant
NINPOINT MEDICAL, INC.
1171 barroilhet ave
hillsborough,  CA  94010
Contact cindy domecus, rac (us & eu)
Regulation Number892.1560
Classification Product Code
NQQ  
Date Received03/16/2012
Decision Date 04/25/2013
Decision substantially equivalent - with limitations (SU)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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