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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Chart, Visual Acuity
510(k) Number K861416
Device Name CANON AUTO ACUITOMETER CV-10
Applicant
Canon USA, Inc.
One Jericho Plz.
Jericho,  NY  11753
Applicant Contact TAMADA
Correspondent
Canon USA, Inc.
One Jericho Plz.
Jericho,  NY  11753
Correspondent Contact TAMADA
Regulation Number886.1150
Classification Product Code
HOX  
Date Received04/15/1986
Decision Date 05/14/1986
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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