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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 K191117
Device Name NvisionVLE Low-profile Optical Probe
Applicant
NinePoint Medical, Inc
12 Oak Park Drive
bedford,  MA  01730
Applicant Contact eman namati
Correspondent
NinePoint Medical, Inc
12 Oak Park Drive
bedford,  MA  01730
Correspondent Contact eman namati
Regulation Number892.1560
Classification Product Code
NQQ  
Date Received04/26/2019
Decision Date 07/19/2019
Decision se - with limitations (SESU)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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