The following data is part of a premarket notification filed by The Lagado Corp. with the FDA for Tyro 97 (hofocon A) Rigid Gas Permeable Spherical, Aspheric, Toric And Bifocal Contact Lenses For Daily Wear.
Device ID | K052507 |
510k Number | K052507 |
Device Name: | TYRO 97 (HOFOCON A) RIGID GAS PERMEABLE SPHERICAL, ASPHERIC, TORIC AND BIFOCAL CONTACT LENSES FOR DAILY WEAR |
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 | 2005-09-13 |
Decision Date | 2005-11-02 |
Summary: | summary |