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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact, Polymethylmethacrylate, Diagnostic
510(k) Number K940107
Device Name VIRECTOMY LENS
Applicant
Visionary Technologies of Miami, Inc.
8306 Mills Dr., Suite 147
Miami,  FL  33183
Applicant Contact THOMAS MESTRITS
Correspondent
Visionary Technologies of Miami, Inc.
8306 Mills Dr., Suite 147
Miami,  FL  33183
Correspondent Contact THOMAS MESTRITS
Regulation Number886.1385
Classification Product Code
HJK  
Date Received01/10/1994
Decision Date 09/06/1994
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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