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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Ophthalmic, Ac-Powered
510(k) Number K132186
Device Name OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2
Applicant
Optomed OY
Hallituskatu 13-17 D
Oulu,  FI 90100
Applicant Contact JYRI LESKELA, QUALITY MANAGER
Correspondent
Optomed OY
Hallituskatu 13-17 D
Oulu,  FI 90100
Correspondent Contact JYRI LESKELA, QUALITY MANAGER
Regulation Number886.1120
Classification Product Code
HKI  
Date Received07/15/2013
Decision Date 12/18/2013
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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