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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 K991780
Device Name FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C
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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