The following data is part of a premarket notification filed by Iop, Inc. with the FDA for Molteno Implant.
| Device ID | K890598 |
| 510k Number | K890598 |
| Device Name: | MOLTENO IMPLANT |
| 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 | 1989-02-06 |
| Decision Date | 1989-02-27 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MOLTENO IMPLANT 73722158 1578807 Dead/Cancelled |
MOLTENO, ANTHONY C.B. 1988-04-13 |