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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chart, Visual Acuity
510(k) Number K853736
Device Name MENTOR BRIGHTNESS ACUITY TESTER
Applicant
MENTOR O & O, INC.
SOUTH SHORE PARK
HINGHAM,  MA  02043
Applicant Contact DAVID M LINK
Correspondent
MENTOR O & O, INC.
SOUTH SHORE PARK
HINGHAM,  MA  02043
Correspondent Contact DAVID M LINK
Regulation Number886.1150
Classification Product Code
HOX  
Date Received09/06/1985
Decision Date 11/01/1985
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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