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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Management, Ophthalmic
510(k) Number K013694
Device Name NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)
Applicant
Nidek, Inc.
21911 Erie Ln.
Lake Forest,  CA  92630
Applicant Contact CAROL PATTERSON
Correspondent
Nidek, Inc.
21911 Erie Ln.
Lake Forest,  CA  92630
Correspondent Contact CAROL PATTERSON
Regulation Number892.2050
Classification Product Code
NFJ  
Date Received11/07/2001
Decision Date 11/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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