The following data is part of a premarket notification filed by Lombart Lenses, Ltd. with the FDA for Ll-55 (methafilcon A) For Daily Wear.
| Device ID | K941877 |
| 510k Number | K941877 |
| Device Name: | LL-55 (METHAFILCON A) FOR DAILY WEAR |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | LOMBART LENSES, LTD. 1215 BOISSEVAIN AVE. Norfolk, VA 23507 |
| Contact | Lisa Hahn |
| Correspondent | Lisa Hahn LOMBART LENSES, LTD. 1215 BOISSEVAIN AVE. Norfolk, VA 23507 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-18 |
| Decision Date | 1994-06-14 |