The following data is part of a premarket notification filed by New World Medical, Inc. with the FDA for Ahmed Glaucoma Valve Implant.
| Device ID | K925636 |
| 510k Number | K925636 |
| Device Name: | AHMED GLAUCOMA VALVE IMPLANT |
| Classification | Implant, Eye Valve |
| Applicant | NEW WORLD MEDICAL, INC. 10574 ACACIA ST. SUITE D-1 Rancho Cucamonga, CA 91730 |
| Contact | Mateen Ahmed |
| Correspondent | Mateen 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 | 1992-11-09 |
| Decision Date | 1993-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00892064002133 | K925636 | 000 |