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 |