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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
Device Name NVISION VLE IMAGING SYSTEM
Applicant
Ninepoint Medical, Inc.
1171 Barroilhet Ave.
Hillsborough,  CA  94010
Applicant Contact CINDY DOMECUS, RAC (US & EU)
Correspondent
Ninepoint Medical, Inc.
1171 Barroilhet Ave.
Hillsborough,  CA  94010
Correspondent Contact CINDY DOMECUS, RAC (US & EU)
Regulation Number892.1560
Classification Product Code
NQQ  
Date Received03/16/2012
Decision Date 04/25/2013
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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