The following data is part of a premarket notification filed by Igel Vision Care Pte Ltd. with the FDA for Igel 56 Uv (hefilcon C) Soft (hydrophilic) Contact Lens.
Device ID | K984523 |
510k Number | K984523 |
Device Name: | IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS |
Classification | Lenses, Soft Contact, Daily Wear |
Applicant | IGEL VISION CARE PTE LTD. 203 N. WABASH, STE 1200 Chicago,, IL 60601 |
Contact | John M Szabocsik |
Correspondent | John M Szabocsik IGEL VISION CARE PTE LTD. 203 N. WABASH, STE 1200 Chicago,, IL 60601 |
Product Code | LPL |
CFR Regulation Number | 886.5925 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-12-21 |
Decision Date | 1999-02-16 |
Summary: | summary |