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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 St.
Plano,  TX  75024
Applicant Contact ERIC LUO
Correspondent
Suzhou 66 Vision-Tech Co., Ltd.
6833 Saint Lawrence St.
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
Predetermined Change
Control Plan Authorized		 No
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