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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 K012852
Device Name EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS
Applicant
OPTONOL, LTD
12300 TWINBROOK PKWY, STE 625
ROCKVILLE,  MD  20852
Applicant Contact RICHARD E LIPPMAN
Correspondent
OPTONOL, LTD
12300 TWINBROOK PKWY, STE 625
ROCKVILLE,  MD  20852
Correspondent Contact RICHARD E LIPPMAN
Regulation Number886.3920
Classification Product Code
KYF  
Date Received08/24/2001
Decision Date 03/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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