The following data is part of a premarket notification filed by G.t. Laboratories, Inc. with the FDA for Fluorex Ultra (flusilfocon E) Rigid Gas Permeable Contact Lens.
| Device ID | K991781 |
| 510k Number | K991781 |
| Device Name: | FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | G.T. LABORATORIES, INC. 203 NORTH WABASH AVE. SUITE 1200 Chicago, IL 60601 |
| Contact | John M Szabocsik |
| Correspondent | John M Szabocsik G.T. LABORATORIES, INC. 203 NORTH WABASH AVE. SUITE 1200 Chicago, IL 60601 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-25 |
| Decision Date | 1999-06-29 |
| Summary: | summary |