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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name camera, ophthalmic, ac-powered
510(k) Number K862323
Device Name CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM
Applicant
CANON U.S.A., INC.
ONE JERICHO PLAZA
JERICHO,  NY  11753 -1000
Applicant Contact TAMADA
Correspondent
CANON U.S.A., INC.
ONE JERICHO PLAZA
JERICHO,  NY  11753 -1000
Correspondent Contact TAMADA
Regulation Number886.1120
Classification Product Code
HKI  
Date Received06/19/1986
Decision Date 08/21/1986
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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