The following data is part of a premarket notification filed by The Lagado Corp. with the FDA for Onsi -56 (onsifocon A) Rigid Gas Permeable Spherical, Aspheric, Toric And Bifocal Contact Lens.
| Device ID | K033599 |
| 510k Number | K033599 |
| Device Name: | ONSI -56 (ONSIFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENS |
| Classification | Lens, Contact (other Material) - Daily |
| Applicant | THE LAGADO CORP. 203 NORTH WABASH AVENUE SUITE 1200 Chicago, IL 60601 |
| Contact | John M Szabocsik |
| Correspondent | John M Szabocsik THE LAGADO CORP. 203 NORTH WABASH AVENUE SUITE 1200 Chicago, IL 60601 |
| Product Code | HQD |
| CFR Regulation Number | 886.5916 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-14 |
| Decision Date | 2004-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858174006041 | K033599 | 000 |