The following data is part of a premarket notification filed by New World Medical, Inc. with the FDA for Ahmed Glaucoma Valve.
| Device ID | K162060 |
| 510k Number | K162060 |
| Device Name: | Ahmed Glaucoma Valve |
| Classification | Implant, Eye Valve |
| Applicant | NEW WORLD MEDICAL, INC. 10763 EDISON COURT Rancho Cucamonga, CA 91730 |
| Contact | Suhail Abdullah |
| Correspondent | Suhail Abdullah NEW WORLD MEDICAL, INC. 10763 EDISON COURT 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 | 2016-07-26 |
| Decision Date | 2016-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00892064002188 | K162060 | 000 |
| 00892064002119 | K162060 | 000 |