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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K161764
Device Name SLIT LAMP, Model: YF-100
Applicant
Chongqing Yeasn Science-Technology Co., Ltd.
5 Danlong Rd.
Nan'An District,  CN 400060
Applicant Contact BING HU
Correspondent
Sgs-Ctsc Standards Technical Services Co., Ltd.
198 Kezhu Rd., Scientech Park Guangzhou Economic &
Technology Development District
Guangzhou,  CN
Correspondent Contact IRIS FUNG
Regulation Number886.1850
Classification Product Code
HJO  
Date Received06/27/2016
Decision Date 02/16/2017
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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