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 |