The following data is part of a premarket notification filed by Hydron Ltd. with the FDA for Actifresh 400 Lens.
| Device ID | K983637 |
| 510k Number | K983637 |
| Device Name: | ACTIFRESH 400 LENS |
| 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 | 1998-10-16 |
| Decision Date | 1999-12-10 |
| Summary: | summary |