The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Biomedics (ocufilcon D) Soft (hydrophilic) Contact Lens.
| Device ID | K091339 |
| 510k Number | K091339 |
| Device Name: | BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | COOPERVISION, INC. 1215 BOISSEVAIN AVE. Norfolk, VA 23507 |
| Contact | Lisa Hahn |
| Correspondent | Lisa Hahn COOPERVISION, 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 | 2009-05-06 |
| Decision Date | 2010-01-05 |
| Summary: | summary |