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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name photostimulator, ac-powered
510(k) Number K983983
Device Name EDI VERIS SYSTEM
Applicant
ELECTRO-DIAGNOSTIC IMAGING, INC.
2081 LONGDEN CIRCLE
LOS ALTOS,  CA  94024
Applicant Contact SHEILA W PICKERING
Correspondent
ELECTRO-DIAGNOSTIC IMAGING, INC.
2081 LONGDEN CIRCLE
LOS ALTOS,  CA  94024
Correspondent Contact SHEILA W PICKERING
Regulation Number886.1630
Classification Product Code
HLX  
Date Received11/09/1998
Decision Date 02/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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