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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 K100439
Device Name MEDIWORKS SLIT LAMP
Applicant
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD.
1485 ANDREW DR
SUITE G
CLAREMONT,  CA  91711
Applicant Contact LISA ZHANG
Correspondent
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD.
1485 ANDREW DR
SUITE G
CLAREMONT,  CA  91711
Correspondent Contact LISA ZHANG
Regulation Number886.1850
Classification Product Code
HJO  
Date Received02/17/2010
Decision Date 07/16/2010
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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