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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 K182616
Device Name NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
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 Received09/21/2018
Decision Date 11/02/2018
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
Predetermined Change
Control Plan Authorized		 No
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