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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tomography, Optical Coherence
510(k) Number K121043
Device Name OPTOS OCT/SLO MICROPERIMETER
Applicant
Optos Plc.
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact RANDY J PREBULA
Correspondent
Optos Plc.
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact RANDY J PREBULA
Regulation Number886.1570
Classification Product Code
OBO  
Subsequent Product Code
HPT  
Date Received04/05/2012
Decision Date 02/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
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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