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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 K133062
Device Name DISCOVERY SYSTEM
Applicant
Innovative Visual Systems
386 N. York Rd. Suite 209
Elmhurst,  IL  60126
Applicant Contact DONALD R SANDERS, M.D. PH.D
Correspondent
Innovative Visual Systems
386 N. York Rd. Suite 209
Elmhurst,  IL  60126
Correspondent Contact DONALD R SANDERS, M.D. PH.D
Regulation Number886.1850
Classification Product Code
HJO  
Subsequent Product Codes
HKO   MMQ  
Date Received09/27/2013
Decision Date 06/20/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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