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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 K153283
Device Name VivoSight Dx Topical OCT System
Applicant
Michelson Diagnostics Ltd
Ground Floor Eclipse House, Eclipse Park, Sittingbourne Road
Maidstone,  GB me14 3en
Applicant Contact Martin Johns
Correspondent
Michelson Diagnostics Ltd
Ground Floor Eclipse House, Eclipse Park, Sittingbourne Road
Maidstone,  GB me14 3en
Correspondent Contact Martin Johns
Regulation Number892.1560
Classification Product Code
NQQ  
Date Received11/12/2015
Decision Date 08/11/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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