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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 K030350
Device Name EXPRESS MINI GLAUCOMA SHUNT
Applicant
Optonol, Ltd.
Surgical Business Unit
11460 Johns Creek Pkwy.
Duluth,  GA  30097
Applicant Contact PENNY NORTHCUTT
Correspondent
Optonol, Ltd.
Surgical Business Unit
11460 Johns Creek Pkwy.
Duluth,  GA  30097
Correspondent Contact PENNY NORTHCUTT
Regulation Number886.3920
Classification Product Code
KYF  
Date Received02/03/2003
Decision Date 03/13/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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