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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 (Other Material) - Daily
510(k) Number K052507
Device Name TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR
Applicant
The Lagado Corp.
203 N. Wabash Ave. Suite 1200
Chicago,  IL  60601
Applicant Contact JOHN M SZABOCSIK
Correspondent
The Lagado Corp.
203 N. Wabash Ave. Suite 1200
Chicago,  IL  60601
Correspondent Contact JOHN M SZABOCSIK
Regulation Number886.5916
Classification Product Code
HQD  
Date Received09/13/2005
Decision Date 11/02/2005
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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