K082855 is an FDA 510(k) clearance for the MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES. 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 March 9, 2010, 526 days after receiving the submission on September 29, 2008.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5918.
| 510(k) Number | K082855 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2008 |
| Decision Date | March 09, 2010 |
| Days to Decision | 526 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 |