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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratoscope, Ac-Powered
510(k) Number K871936
Device Name CANON SURGICAL AUTO KERATOMETER SK-1
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 Number886.1350
Classification Product Code
HLQ  
Date Received05/18/1987
Decision Date 06/19/1987
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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