The following data is part of a premarket notification filed by Menicon Co. Ltd. with the FDA for Menicon Progent Protein Remover For Rigid Gas Permeable Contact Lenses.
| Device ID | K082855 |
| 510k Number | K082855 |
| Device Name: | MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES |
| Classification | Products, Contact Lens Care, Rigid Gas Permeable |
| Applicant | MENICON CO. LTD. 187 BALLARDVALE STREET SUITE 180 Wilmington, MA 01887 |
| Contact | Beverley D Venuti |
| Correspondent | Beverley D Venuti MENICON CO. LTD. 187 BALLARDVALE STREET SUITE 180 Wilmington, MA 01887 |
| Product Code | MRC |
| CFR Regulation Number | 886.5918 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-29 |
| Decision Date | 2010-03-09 |
| Summary: | summary |