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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 K163475
Device Name iVue
Applicant
Optovue, Inc.
2800 Bayview Drive
Fremont,  CA  94538
Applicant Contact Edward J. Sinclair
Correspondent
Optovue, Inc.
2800 Bayview Drive
Fremont,  CA  94538
Correspondent Contact Edward J. Sinclair
Regulation Number886.1570
Classification Product Code
OBO  
Subsequent Product Code
HLI  
Date Received12/12/2016
Decision Date 06/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT02775097
NCT02781948
Reviewed by Third Party No
Combination Product No
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