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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 K854983
Device Name OPTRONICS CONTRAST ACUITY TESTER
Applicant
Optronics, Inc.
200 E. Buffalo St.
Ithaca,  NY  14850
Applicant Contact PHILLIP LEMPERT
Correspondent
Optronics, Inc.
200 E. Buffalo St.
Ithaca,  NY  14850
Correspondent Contact PHILLIP LEMPERT
Regulation Number886.1150
Classification Product Code
HOX  
Date Received12/12/1985
Decision Date 02/04/1986
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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