The following data is part of a premarket notification filed by New World Medical, Inc. with the FDA for Ahmed Glaucoma Valve, Model S3.
| Device ID | K980657 |
| 510k Number | K980657 |
| Device Name: | AHMED GLAUCOMA VALVE, MODEL S3 |
| Classification | Implant, Eye Valve |
| Applicant | NEW WORLD MEDICAL, INC. 10574 ACACIA ST. SUITE D-1 Rancho Cucamonga, CA 91730 |
| Contact | A.m. Ahmed |
| Correspondent | A.m. Ahmed NEW WORLD MEDICAL, INC. 10574 ACACIA ST. SUITE D-1 Rancho Cucamonga, CA 91730 |
| Product Code | KYF |
| CFR Regulation Number | 886.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-05 |
| Decision Date | 1998-04-20 |
| Summary: | summary |