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 | K962006 |
| 510k Number | K962006 |
| Device Name: | MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | MENICON CO. LTD. 700 THIRTEENTH STREET, N.W., SUITE 1200 Washington, DC 20005 |
| Contact | A. Wes Siegner,, Jr. |
| Correspondent | A. Wes Siegner,, Jr. MENICON CO. LTD. 700 THIRTEENTH STREET, N.W., SUITE 1200 Washington, DC 20005 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-22 |
| Decision Date | 1996-10-09 |
| Summary: | summary |