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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 K991781
Device Name FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS
Applicant
G.T. LABORATORIES, INC.
203 NORTH WABASH AVE.
SUITE 1200
CHICAGO,  IL  60601
Applicant Contact JOHN M SZABOCSIK
Correspondent
G.T. LABORATORIES, INC.
203 NORTH WABASH AVE.
SUITE 1200
CHICAGO,  IL  60601
Correspondent Contact JOHN M SZABOCSIK
Regulation Number886.5916
Classification Product Code
HQD  
Date Received05/25/1999
Decision Date 06/29/1999
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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