The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Renu Multiplus Multi-purpose Solution.
| Device ID | K001539 |
| 510k Number | K001539 |
| Device Name: | RENU MULTIPLUS MULTI-PURPOSE SOLUTION |
| Classification | Accessories, Soft Lens Products |
| Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
| Contact | Paul G Stapleton |
| Correspondent | Paul G Stapleton BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14609 -3547 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-17 |
| Decision Date | 2000-07-31 |