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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 K090266
Device Name MATCHEDFLICKER
Applicant
Eyeic Corporation
1920 Arlington Pl.
Madison,  WI  53726
Applicant Contact MORRIS WAXLER
Correspondent
Eyeic Corporation
1920 Arlington Pl.
Madison,  WI  53726
Correspondent Contact MORRIS WAXLER
Regulation Number892.2050
Classification Product Code
NFJ  
Date Received02/03/2009
Decision Date 05/06/2009
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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