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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 K093520
Device Name VIVOSIGHT TOPICAL OCT SYSTEM
Applicant
Michelson Diagnostics, Ltd.
11a Grays Farm Production Vill
Grays Farm Rd.
Orpington, Kent,  GB BR5 3BD
Applicant Contact MARTIN JOHNS
Correspondent
Michelson Diagnostics, Ltd.
11a Grays Farm Production Vill
Grays Farm Rd.
Orpington, Kent,  GB BR5 3BD
Correspondent Contact MARTIN JOHNS
Regulation Number892.1560
Classification Product Code
NQQ  
Date Received11/13/2009
Decision Date 01/05/2010
Decision Substantially Equivalent (SESE)
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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