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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
Predetermined Change
Control Plan Authorized		 No
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