The following data is part of a premarket notification filed by Staar Surgical Co. with the FDA for Molteno Valve Seton.
| Device ID | K875099 |
| 510k Number | K875099 |
| Device Name: | MOLTENO VALVE SETON |
| Classification | Implant, Eye Valve |
| Applicant | STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
| Contact | Jason Malecka |
| Correspondent | Jason Malecka STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
| Product Code | KYF |
| CFR Regulation Number | 886.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-10 |
| Decision Date | 1988-03-30 |