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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 K942242
Device Name AUTO REF-KERATOMETER, RK-3
Applicant
CANNON U.S.A., INC.
ONE CANNON PLAZA
LAKE SUCCESS,  NY  11042
Applicant Contact HIROYUKI TAKAHASHI
Correspondent
CANNON U.S.A., INC.
ONE CANNON PLAZA
LAKE SUCCESS,  NY  11042
Correspondent Contact HIROYUKI TAKAHASHI
Regulation Number886.1760
Classification Product Code
HKO  
Subsequent Product Code
HLQ  
Date Received05/09/1994
Decision Date 09/02/1994
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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