The following data is part of a premarket notification filed by Johnson & Johnson Vision Care, Inc. with the FDA for Acuvue (etafilcon A) Contact Lens, Clear And With Visibility Tint With Uv Blocker, For Daily Wear.
| Device ID | K051900 |
| 510k Number | K051900 |
| Device Name: | ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKER, FOR DAILY WEAR |
| Classification | Lens, Contact, (disposable) |
| Applicant | JOHNSON & JOHNSON VISION CARE, INC. 7500 CENTURION PKWY. SUITE 100 Jacksonville, FL 32256 |
| Contact | Susan Morris |
| Correspondent | Susan Morris JOHNSON & JOHNSON VISION CARE, INC. 7500 CENTURION PKWY. SUITE 100 Jacksonville, FL 32256 |
| Product Code | MVN |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-13 |
| Decision Date | 2005-08-12 |
| Summary: | summary |