The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Bausch & Lomb Renu Rewetting & Lubricating Drops.
| Device ID | K874364 |
| 510k Number | K874364 |
| Device Name: | BAUSCH & LOMB RENU REWETTING & LUBRICATING DROPS |
| Classification | Accessories, Soft Lens Products |
| Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O.BOX 450 Rochester, NY 14692 |
| Contact | Davies, O.d. |
| Correspondent | Davies, O.d. BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O.BOX 450 Rochester, NY 14692 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-23 |
| Decision Date | 1987-11-25 |