The following data is part of a premarket notification filed by Biocompatibles Eyewear, Inc. with the FDA for Proclear (omafilcon A) Daily Wear Contact Lens.
| Device ID | K974408 |
| 510k Number | K974408 |
| Device Name: | PROCLEAR (OMAFILCON A) DAILY WEAR CONTACT LENS |
| 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 | 1997-11-24 |
| Decision Date | 1998-04-16 |
| Summary: | summary |