The following data is part of a premarket notification filed by Innovision, Inc. with the FDA for Hydro2, Hs-75.
| Device ID | K000485 |
| 510k Number | K000485 |
| Device Name: | HYDRO2, HS-75 |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | INNOVISION, INC. 3125 SOUTH 61ST AVE. Omaha, NE 68106 -3675 |
| Contact | Don M Woodford |
| Correspondent | Don M Woodford INNOVISION, INC. 3125 SOUTH 61ST AVE. Omaha, NE 68106 -3675 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-14 |
| Decision Date | 2000-05-12 |