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510(k) Data Aggregation
K Number
K100439Device Name
MEDIWORKS SLIT LAMP
Date Cleared
2010-07-16
(149 days)
Product Code
Regulation Number
886.1850Why did this record match?
Applicant Name (Manufacturer) :
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MediWorks Model S280, S280S, S350, S350S Slit Lamps are AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. They are used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.
Device Description
AC-powered slit lamp biomicroscopes
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