FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS


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

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