The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Aquair (enfilcon A) Soft (hydrophilic) Contact Lens.
| Device ID | K071736 |
| 510k Number | K071736 |
| Device Name: | AQUAIR (ENFILCON A) SOFT (HYDROPHILIC) CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | COOPERVISION, INC. 6140 STONERIDGE MALL ROAD SUITE 500 Pleasanton, CA 94588 |
| Contact | Jack P Douglas |
| Correspondent | Jack P Douglas COOPERVISION, INC. 6140 STONERIDGE MALL ROAD SUITE 500 Pleasanton, CA 94588 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-26 |
| Decision Date | 2008-01-04 |
| Summary: | summary |