The following data is part of a premarket notification filed by Foresight Regulatory Strategies with the FDA for Menicon Nect Contact Lens Case.
| Device ID | K131875 |
| 510k Number | K131875 |
| Device Name: | MENICON NECT CONTACT LENS CASE |
| Classification | Case, Contact Lens |
| Applicant | FORESIGHT REGULATORY STRATEGIES 187 BALLARDVALE STREET SUITE 180 Wilmington, MA 01887 -4461 |
| Contact | Ellen M Beucler |
| Correspondent | Ellen M Beucler FORESIGHT REGULATORY STRATEGIES 187 BALLARDVALE STREET SUITE 180 Wilmington, MA 01887 -4461 |
| Product Code | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-24 |
| Decision Date | 2013-08-06 |
| Summary: | summary |