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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 K033190
Device Name VISION-TECH YZ SLIT LAMP, MODEL 66
Applicant
SUZHOU 66 VISION-TECH CO., LTD
6833 SAINT LAWRENCE STREET
PLANO,  TX  75024
Applicant Contact ERIC LUO
Correspondent
SUZHOU 66 VISION-TECH CO., LTD
6833 SAINT LAWRENCE STREET
PLANO,  TX  75024
Correspondent Contact ERIC LUO
Regulation Number886.1850
Classification Product Code
HJO  
Date Received10/01/2003
Decision Date 12/04/2003
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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