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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Fundus, Hruby, Diagnostic
510(k) Number K901839
Device Name 60 FUNDUS CAMERA CF-60UV
Applicant
Canon USA, Inc.
One Jericho Plz.
Jericho,  NY  11753
Applicant Contact TAKAHASHI
Correspondent
Canon USA, Inc.
One Jericho Plz.
Jericho,  NY  11753
Correspondent Contact TAKAHASHI
Regulation Number886.1395
Classification Product Code
HJI  
Date Received04/24/1990
Decision Date 07/05/1990
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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