MEDIWORKS SLIT LAMP— 510(k) K100439

Name: FDA 510(k) clearance K100439
Creator: U.S. Food and Drug Administration
Published: 2010-07-16

Substantially Equivalent

Shanghai Mediworks Precision Instruments Co. , Ltd.

FDA 510(k) clearance K100439 for MEDIWORKS SLIT LAMP, Substantially Equivalent on 2010-07-16. Applicant: Shanghai Mediworks Precision Instruments Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai Mediworks Precision Instruments Co. , Ltd.
Product code: Code HJO
Device class: Class 2
Regulation: 21 CFR 886.1850
Advisory panel: Ophthalmic
Date received: 2010-02-17
Decision date: 2010-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Claremont, CA, US

Download summary PDF View on FDA.gov ↗

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