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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tomography, optical coherence
510(k) Number K111505
Device Name RTVUE CAM WITH CORNEAL POWER UPGRADE
Applicant
OPTOVUE, INC.
45531 NORTHPORT LOOP W.
FREMONT,  CA  94538
Applicant Contact JOHN TALARICO
Correspondent
OPTOVUE, INC.
45531 NORTHPORT LOOP W.
FREMONT,  CA  94538
Correspondent Contact JOHN TALARICO
Regulation Number886.1570
Classification Product Code
OBO  
Subsequent Product Code
MMQ  
Date Received05/31/2011
Decision Date 09/08/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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