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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Laser, Scanning
510(k) Number K142897
Device Name P200DTx
Applicant
OPTOS PLC.
QUEENSFERRY HOUSE, CARNEGIE BUSINESS CAMPUS
DUNFERMLINE,  GB KY11 8GR
Applicant Contact GUNHILD PAULSEN
Correspondent
HOGAN LOVELLS US LLP
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Correspondent Contact RANDY PREBULA
Regulation Number886.1570
Classification Product Code
MYC  
Date Received10/03/2014
Decision Date 01/16/2015
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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