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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)
510(k) Number K940106
Device Name KERATOPLASTY SUTURING 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
Classification Product Code
HPX  
Date Received01/10/1994
Decision Date 05/25/1994
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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