K130805 is an FDA 510(k) clearance for the MENICON UNIQUE PH MULTI-PURPOSE SOLUTION. This device is classified as a Products, Contact Lens Care, Rigid Gas Permeable (Class II - Special Controls, product code MRC).
Submitted by Menicon Co, Ltd. (Wilmington, US). The FDA issued a Cleared decision on July 3, 2013, 100 days after receiving the submission on March 25, 2013.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5918.
| 510(k) Number | K130805 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2013 |
| Decision Date | July 03, 2013 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| 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 |