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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
Model RTVUE100
Device Name RTVUE CAM WITH CORNEAL POWER UPGRADE
Applicant
OPTOVUE, INC.
45531 northport loop w.
fremont,  CA  94538
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 (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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