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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 K102013
Device Name DIGITAL RETINAL CAMERA
Applicant
Canon Inc. -Medical Equipment Group
3f 2-17-6 Akebono-Cho
Tachikawa-Shi, Tokyo,  JP 190-0012
Applicant Contact KOJI KUBO
Correspondent
Canon Inc. -Medical Equipment Group
3f 2-17-6 Akebono-Cho
Tachikawa-Shi, Tokyo,  JP 190-0012
Correspondent Contact KOJI KUBO
Regulation Number886.1120
Classification Product Code
HKI  
Date Received07/16/2010
Decision Date 10/29/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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