The following data is part of a premarket notification filed by Menicon Co. Ltd. with the FDA for Melafocon A/rigid Gas Perm Contact Len For Daily Wear.
| Device ID | K943784 |
| 510k Number | K943784 |
| Device Name: | MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAR |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | MENICON CO. LTD. 700 THIRTEENTH STREET, N.W., SUITE 1200 Washington, DC 20005 |
| Contact | A. Wes Siegner |
| Correspondent | A. Wes Siegner 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 | 1994-07-26 |
| Decision Date | 1994-10-20 |