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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 K091404
Device Name IVUE, MODEL 100
Applicant
Optovue, Inc.
45531 Northport Loop W
Fremont,  CA  94538
Applicant Contact Azimun Jamal
Correspondent
Optovue, Inc.
45531 Northport Loop W
Fremont,  CA  94538
Correspondent Contact Azimun Jamal
Regulation Number886.1570
Classification Product Code
OBO  
Date Received05/12/2009
Decision Date 04/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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