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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tester, color vision
510(k) Number K832843
Device Name OSCAR COLOUR VISION TESTER
Applicant
KEELER INSTRUMENTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
KEELER INSTRUMENTS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.1170
Classification Product Code
HIT  
Date Received08/22/1983
Decision Date 01/04/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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