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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 K090466
Device Name DIGITAL RETINAL CAMERA, CR-1 MARK II
Applicant
CANON, INC.
ONE CANON PLAZA
LAKE SUCCESS,  NY  11042 -1198
Applicant Contact SHEILA DRISCOLL
Correspondent
UNDERWRITERS LABORATORIES, INC.
1285 WALT WHITMAN RD.
MELVILLE,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number886.1120
Classification Product Code
HKI  
Date Received02/21/2009
Decision Date 03/23/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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