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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 K180660
Device Name Avanti
Applicant
Optovue, Inc.
2800 Bayview Drive
Fremont,  CA  94538
Applicant Contact Indu Lakshman
Correspondent
Optovue, Inc.
2800 Bayview Drive
Fremont,  CA  94538
Correspondent Contact Indu Lakshman
Regulation Number886.1570
Classification Product Code
OBO  
Subsequent Product Code
HLI  
Date Received03/14/2018
Decision Date 06/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT02911883
Reviewed by Third Party No
Combination Product No
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