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 | K173136 |
| 510k Number | K173136 |
| Device Name: | Menicon Progent Protein Remover For Rigid Gas Permeable Contact Lenses |
| Classification | Products, Contact Lens Care, Rigid Gas Permeable |
| Applicant | Menicon Co., Ltd. 21-19, Aoi 3, Naka-ku Nagoya, JP 460-0006 |
| Contact | Kenichi Tanaka |
| Correspondent | Ellen M Beucler Foresight Regulatory Strategies, Inc. 187 Ballardvale Street, Suite A250 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 | 2017-09-29 |
| Decision Date | 2017-11-16 |
| Summary: | summary |