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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 K980246
Device Name NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM
Applicant
Canon USA, Inc.
One Canon Plaza
Lake Success,  NY  11042 -1198
Applicant Contact GLENN IMPAL
Correspondent
Canon USA, Inc.
One Canon Plaza
Lake Success,  NY  11042 -1198
Correspondent Contact GLENN IMPAL
Regulation Number886.1120
Classification Product Code
HKI  
Date Received01/23/1998
Decision Date 05/06/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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