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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 K941234
Device Name NON-MYDRIATIC RETINAL CAMERA
Applicant
CANON U.S.A., INC.
ONE CANON PLAZA
LAKE SUCCESS,  NY  11042 -1198
Applicant Contact HIROYUKI TAKAHASHI
Correspondent
CANON U.S.A., INC.
ONE CANON PLAZA
LAKE SUCCESS,  NY  11042 -1198
Correspondent Contact HIROYUKI TAKAHASHI
Regulation Number886.1120
Classification Product Code
HKI  
Date Received03/15/1994
Decision Date 06/07/1995
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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