The following data is part of a premarket notification filed by Menicon Co. Ltd. with the FDA for Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lens.
| Device ID | K103561 |
| 510k Number | K103561 |
| Device Name: | MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS |
| Classification | Lens, Contact (other Material) - Daily |
| 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 | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-06 |
| Decision Date | 2011-02-03 |
| Summary: | summary |