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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
Original Applicant
OPTOS PLC
555 thirteenth st. n.w.
washington,  DC  20004
Original 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 (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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