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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 K934663
Device Name 60 DEGREE FUNDUS CAMERA, CF-60UD
Applicant
CANON U.S.A., INC.
ONE CANON PLAZA
LAKE SUCCESS,  NY  11042 -1198
Applicant Contact MR. TAKAHASHI
Correspondent
CANON U.S.A., INC.
ONE CANON PLAZA
LAKE SUCCESS,  NY  11042 -1198
Correspondent Contact MR. TAKAHASHI
Regulation Number886.1120
Classification Product Code
HKI  
Date Received09/28/1993
Decision Date 02/22/1994
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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