The following data is part of a premarket notification filed by Iop, Inc. with the FDA for Modified Molteno(tm) Implants.
| Device ID | K902489 |
| 510k Number | K902489 |
| Device Name: | MODIFIED MOLTENO(TM) IMPLANTS |
| Classification | Implant, Eye Valve |
| Applicant | IOP, INC. 22653 PACIFIC COAST HWY SUITE 340 Malibu, CA 90265 |
| Contact | Jason Malecka |
| Correspondent | Jason Malecka IOP, INC. 22653 PACIFIC COAST HWY SUITE 340 Malibu, CA 90265 |
| Product Code | KYF |
| CFR Regulation Number | 886.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-16 |
| Decision Date | 1990-08-14 |