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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 K152429
Device Name Slit Lamp Microscope
Applicant
Shanghai Mediworks Precision Instruments Co. , Ltd.
Zone A, 2nd Floor, # 69, Lane
1985, Chunshen Rd. Minhang District,
Shanghai,  CN 200237
Applicant Contact WEIDA ZHAN
Correspondent
Shanghai Mediworks Precision Instruments Co. , Ltd.
Zone A, 2nd Floor, # 69, Lane
1985, Chunshen Rd. Minhang District,
Shanghai,  CN 200237
Correspondent Contact WEIDA ZHAN
Regulation Number886.1850
Classification Product Code
HJO  
Date Received08/26/2015
Decision Date 05/11/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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