The following data is part of a premarket notification filed by Advanced Medical Optics, Inc. with the FDA for Complete Blink-n-clean Lens Drops.
| Device ID | K040839 |
| 510k Number | K040839 |
| Device Name: | COMPLETE BLINK-N-CLEAN LENS DROPS |
| Classification | Products, Contact Lens Care, Rigid Gas Permeable |
| Applicant | ADVANCED MEDICAL OPTICS, INC. 1700 E. ST. ANDREW PLACE P.O. BOX 25162 Santa Ana, CA 92705 -4933 |
| Contact | Paul J Nowacki |
| Correspondent | Paul J Nowacki ADVANCED MEDICAL OPTICS, INC. 1700 E. ST. ANDREW PLACE P.O. BOX 25162 Santa Ana, CA 92705 -4933 |
| Product Code | MRC |
| CFR Regulation Number | 886.5918 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-31 |
| Decision Date | 2004-10-19 |
| Summary: | summary |