The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Oxycor (balafilcon A) Visibility Tinted Contact Lens.
| Device ID | K972454 |
| 510k Number | K972454 |
| Device Name: | OXYCOR (BALAFILCON A) VISIBILITY TINTED CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14692 -0450 |
| Contact | Dennis Hahn |
| Correspondent | Dennis Hahn BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14692 -0450 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-01 |
| Decision Date | 1997-08-08 |
| Summary: | summary |