K040839 is an FDA 510(k) clearance for the COMPLETE BLINK-N-CLEAN LENS DROPS. This device is classified as a Products, Contact Lens Care, Rigid Gas Permeable (Class II - Special Controls, product code MRC).
Submitted by Advanced Medical Optics, Inc. (Santa Ana, US). The FDA issued a Cleared decision on October 19, 2004, 202 days after receiving the submission on March 31, 2004.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5918.
| 510(k) Number | K040839 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2004 |
| Decision Date | October 19, 2004 |
| Days to Decision | 202 days |
| Submission Type | Abbreviated |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | MRC — Products, Contact Lens Care, Rigid Gas Permeable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5918 |