The following data is part of a premarket notification filed by Biocompatibles Eyewear, Inc. with the FDA for Methafilcon A Soft (hydrophilic) Contact Lens For Daily Wear.
| Device ID | K980218 |
| 510k Number | K980218 |
| Device Name: | METHAFILCON A SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | BIOCOMPATIBLES EYEWEAR, INC. 1215 BOISSEVAIN AVE. Norfolk, VA 23507 |
| Contact | Lisa Hahn |
| Correspondent | Lisa Hahn BIOCOMPATIBLES EYEWEAR, INC. 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 | 1998-01-16 |
| Decision Date | 1998-03-23 |
| Summary: | summary |