K962006 is an FDA 510(k) clearance for the MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS. This device is classified as a Lens, Contact (other Material) - Daily (Class II - Special Controls, product code HQD).
Submitted by Menicon Co, Ltd. (Washington, US). The FDA issued a Cleared decision on October 9, 1996, 140 days after receiving the submission on May 22, 1996.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5916.
| 510(k) Number | K962006 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 1996 |
| Decision Date | October 09, 1996 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQD - Lens, Contact (other Material) - Daily |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5916 |