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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chart, Visual Acuity
510(k) Number K834145
Device Name ERGO DIAGNOSTIC CARD
Applicant
American Ergo Systems
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Ergo Systems
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number886.1150
Classification Product Code
HOX  
Date Received12/01/1983
Decision Date 03/16/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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