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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 K844898
Device Name CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM
Applicant
Canon USA, Inc.
One Canon Plz.
Lake Success,  NY  11042
Applicant Contact unknown unknown
Correspondent
Canon USA, Inc.
One Canon Plz.
Lake Success,  NY  11042
Correspondent Contact unknown unknown
Regulation Number886.1120
Classification Product Code
HKI  
Date Received12/17/1984
Decision Date 01/22/1985
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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