The following data is part of a premarket notification filed by Hydron Ltd. with the FDA for Actitoric (ocufilcon A) Soft (hydrophilic) Toric Contact Lens For Daily Wear.
| Device ID | K983160 |
| 510k Number | K983160 |
| Device Name: | ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FOR DAILY WEAR |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | HYDRON LTD. HAWLEY LANE Farnborough, Hants, GB Gu14 8eq |
| Contact | Julian B Holloway |
| Correspondent | Julian B Holloway HYDRON LTD. HAWLEY LANE Farnborough, Hants, GB Gu14 8eq |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-09 |
| Decision Date | 1999-02-18 |
| Summary: | summary |