The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Proclear (omafilcon A) Daily Disposable/daily Wear Soft Contact Lens.
| Device ID | K061948 |
| 510k Number | K061948 |
| Device Name: | PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS |
| Classification | Lens, Contact, (disposable) |
| 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 | MVN |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-10 |
| Decision Date | 2006-11-22 |
| Summary: | summary |