The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Bausch & Lomb Frequent Replacement Case System.
| Device ID | K896685 |
| 510k Number | K896685 |
| Device Name: | BAUSCH & LOMB FREQUENT REPLACEMENT CASE SYSTEM |
| Classification | Case, Contact Lens |
| Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O.BOX 450 Rochester, NY 14692 |
| Contact | Darla J Elkin |
| Correspondent | Darla J Elkin BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O.BOX 450 Rochester, NY 14692 |
| Product Code | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-28 |
| Decision Date | 1989-12-26 |