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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 K131711
Device Name YZ3 PORTABLE SLIT LAMP
Applicant
SUZHOU 66 VISION TECH CO., LTD.
NO. 34 DARU LANE
SUZHOU, JIANGSU,  CN 215005
Applicant Contact HONGLING XIA
Correspondent
SUZHOU 66 VISION TECH CO., LTD.
NO. 34 DARU LANE
SUZHOU, JIANGSU,  CN 215005
Correspondent Contact HONGLING XIA
Regulation Number886.1850
Classification Product Code
HJO  
Date Received06/11/2013
Decision Date 05/09/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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