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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 K925304
Device Name AUTOREF LENSMETER RL-10
Applicant
Canon USA, Inc.
30-2 Shimomaruko
3-Chome Ohta-Ku
Tokyo 146,  JP
Applicant Contact TAKAHASHI
Correspondent
Canon USA, Inc.
30-2 Shimomaruko
3-Chome Ohta-Ku
Tokyo 146,  JP
Correspondent Contact TAKAHASHI
Regulation Number886.1760
Classification Product Code
HKO  
Subsequent Product Code
HLM  
Date Received10/21/1992
Decision Date 02/17/1994
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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