The following data is part of a premarket notification filed by Bausch & Lomb Incorporated with the FDA for Bausch + Lomb Peroxiclear 3% Hydrogen Peroxide Cleaning & Disinfecting Solution.
| Device ID | K132216 |
| 510k Number | K132216 |
| Device Name: | BAUSCH + LOMB PEROXICLEAR 3% HYDROGEN PEROXIDE CLEANING & DISINFECTING SOLUTION |
| Classification | Accessories, Soft Lens Products |
| Applicant | BAUSCH & LOMB INCORPORATED 1400 NORTH GOODMAN ST. Rochester, NY 14609 |
| Contact | Samantha Duffy |
| Correspondent | Samantha Duffy BAUSCH & LOMB INCORPORATED 1400 NORTH GOODMAN ST. Rochester, NY 14609 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-17 |
| Decision Date | 2013-09-09 |
| Summary: | summary |