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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ophthalmoscope, ac-powered
510(k) Number K103266
Device Name ISTAND
Applicant
OPTOVUE, INC.
45531 NORTHPORT LOOP W.
FREMONT,  CA  94538
Applicant Contact JOHN J TALARICO
Correspondent
OPTOVUE, INC.
45531 NORTHPORT LOOP W.
FREMONT,  CA  94538
Correspondent Contact JOHN J TALARICO
Regulation Number886.1570
Classification Product Code
HLI  
Date Received11/04/2010
Decision Date 06/03/2011
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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