The following data is part of a premarket notification filed by G.t. Laboratories, Inc. with the FDA for Fluorex 700 -uv (flusilfocon A), Fluorex 500-uv (flusilfocon B) And Fluorex 300-uv (flusilfocon C) Rigid Gas Permeable C.
| Device ID | K991780 |
| 510k Number | K991780 |
| Device Name: | FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C |
| 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B316FLX700UV0 | K991780 | 000 |
| B316FLX5000 | K991780 | 000 |
| B316FLX300UV0 | K991780 | 000 |