The following data is part of a premarket notification filed by Ciba Vision Corporation with the FDA for See3 (lotrafilcon A) Soft Contact Lens.
| Device ID | K970746 |
| 510k Number | K970746 |
| Device Name: | SEE3 (LOTRAFILCON A) SOFT CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | CIBA VISION CORPORATION 11460 JOHNS CREEK PKWY. Duluth, GA 30097 |
| Contact | Alicia M Plesnarski, Rac |
| Correspondent | Alicia M Plesnarski, Rac CIBA VISION CORPORATION 11460 JOHNS CREEK PKWY. Duluth, GA 30097 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-28 |
| Decision Date | 1997-05-09 |
| Summary: | summary |