The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Bausch & Lomb Premier 90 (balafilcon A) Contact Lens.
| Device ID | K944895 |
| 510k Number | K944895 |
| Device Name: | BAUSCH & LOMB PREMIER 90 (BALAFILCON A) CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O.BOX 450 Rochester, NY 14692 |
| Contact | Michael Santalucia |
| Correspondent | Michael Santalucia BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O.BOX 450 Rochester, NY 14692 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-04 |
| Decision Date | 1994-12-19 |