The following data is part of a premarket notification filed by Advanced Medical Optics, Inc. with the FDA for Lens Plus Rewetting Drops.
| Device ID | K042562 |
| 510k Number | K042562 |
| Device Name: | LENS PLUS REWETTING DROPS |
| Classification | Accessories, Soft Lens Products |
| Applicant | ADVANCED MEDICAL OPTICS, INC. 1700 E. ST. ANDREW PLACE P.O. BOX 25162 Santa Ana, CA 92705 -4933 |
| Contact | Peter Xu |
| Correspondent | Peter Xu ADVANCED MEDICAL OPTICS, INC. 1700 E. ST. ANDREW PLACE P.O. BOX 25162 Santa Ana, CA 92705 -4933 |
| Product Code | LPN |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-21 |
| Decision Date | 2005-07-29 |
| Summary: | summary |