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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
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