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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Eye Valve
510(k) Number K902296
Device Name TRABECULO-SUPRACHOROIDAL SHUNT
Applicant
Visionex, Inc.
1206 Sargent Dr.
Sunnyvale,  CA  94087
Applicant Contact GIN, MBA
Correspondent
Visionex, Inc.
1206 Sargent Dr.
Sunnyvale,  CA  94087
Correspondent Contact GIN, MBA
Regulation Number886.3920
Classification Product Code
KYF  
Date Received05/22/1990
Decision Date 03/14/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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