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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 K120238
FOIA Releasable 510(k) K120238
Device Name RTVUE XR OCT
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 Received01/26/2012
Decision Date 04/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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