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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 K110986
Device Name OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1
Applicant
Optomed OY
Hallituskatu 13-17
D 96
Oulu,  FI 90100
Applicant Contact LAURA PIILA
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number886.1120
Classification Product Code
HKI  
Date Received04/08/2011
Decision Date 05/16/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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