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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 ROAD
NAN'AN DISTRICT,  CN 400060
Applicant Contact BING HU
Correspondent
SGS-CTSC STANDARDS TECHNICAL SERVICES CO., LTD.
198 KEZHU ROAD, 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
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