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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Management, Ophthalmic
510(k) Number K113696
Device Name OPTOS ADVANCE
Applicant
Optos Plc.
555 13th St. NW
Washington,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
Optos Plc.
555 13th St. NW
Washington,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number892.2050
Classification Product Code
NFJ  
Date Received12/16/2011
Decision Date 05/25/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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