K980657 is an FDA 510(k) clearance for the AHMED GLAUCOMA VALVE, MODEL S3. This device is classified as a Implant, Eye Valve (Class II - Special Controls, product code KYF).
Submitted by New World Medical, Inc. (Rancho Cucamonga, US). The FDA issued a Cleared decision on April 20, 1998, 74 days after receiving the submission on February 5, 1998.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.3920.
| 510(k) Number | K980657 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 1998 |
| Decision Date | April 20, 1998 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | KYF - Implant, Eye Valve |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.3920 |