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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 K063717
Device Name CF-1
Applicant
Canon, Inc.
One Canon Plz.
Lake Success,  NY  11042
Applicant Contact SHEILA DRISCOLL
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact JEFFREY D RONGERO
Regulation Number886.1120
Classification Product Code
HKI  
Date Received12/14/2006
Decision Date 01/23/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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