The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Bausch & Lomb Renu Effervescent Enzymatic Contact Lens Cleaner.
| Device ID | K983225 |
| 510k Number | K983225 |
| Device Name: | BAUSCH & LOMB RENU EFFERVESCENT ENZYMATIC CONTACT LENS CLEANER |
| Classification | Accessories, Soft Lens Products |
| Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14692 -0450 |
| Contact | Yvonne E Middlefell |
| Correspondent | Yvonne E Middlefell BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. Rochester, NY 14692 -0450 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-14 |
| Decision Date | 1999-03-29 |
| Summary: | summary |