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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name refractometer, ophthalmic
510(k) Number K841861
Device Name CANON AUTOREF R-10
Applicant
CANON U.S.A., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CANON U.S.A., INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number886.1760
Classification Product Code
HKO  
Date Received05/04/1984
Decision Date 10/05/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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