The following data is part of a premarket notification filed by New World Medical, Inc. with the FDA for Ahmed Glaucoma Valve, Model M4.
| Device ID | K060644 |
| 510k Number | K060644 |
| Device Name: | AHMED GLAUCOMA VALVE, MODEL M4 |
| Classification | Implant, Eye Valve |
| Applicant | NEW WORLD MEDICAL, INC. 10763 EDISON CT. Rancho Cucamonga, CA 91730 |
| Contact | A. Mateen Ahmed |
| Correspondent | A. Mateen Ahmed NEW WORLD MEDICAL, INC. 10763 EDISON CT. 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 | 2006-03-10 |
| Decision Date | 2006-09-18 |
| Summary: | summary |