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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 K102154
Device Name TYRO-97 (HOFOCON A), ONSI 56 (HOFOCON), RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS
Applicant
THE LAGADO CORP.
203 NORTH WABASH,
STE 2208
CHICAGO,  IL  60601
Applicant Contact JOHN M SZABOCISK
Correspondent
THE LAGADO CORP.
203 NORTH WABASH,
STE 2208
CHICAGO,  IL  60601
Correspondent Contact JOHN M SZABOCISK
Regulation Number886.5916
Classification Product Code
HQD  
Date Received07/30/2010
Decision Date 01/21/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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