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


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

Correspodent Contact john m szabocsik
Regulation Number 886.5916
Classification Product Code
HQD  
Date Received 05/25/1999
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