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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K813313
Device Name BIOMICROSCOPY CONTACT LENS
Applicant
Design Research Assoc., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Design Research Assoc., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number886.1850
Classification Product Code
HJO  
Date Received11/24/1981
Decision Date 03/01/1982
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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