The following data is part of a premarket notification filed by Vistakon, Johnson & Johnson Vision Products, Inc. with the FDA for Acuvue (etafilcon A) Contact Lens Clear & W/visibility Tint W/uv Blocker.
| Device ID | K962804 |
| 510k Number | K962804 |
| Device Name: | ACUVUE (ETAFILCON A) CONTACT LENS CLEAR & W/VISIBILITY TINT W/UV BLOCKER |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. P.O. BOX 10157 Jacksonville, FL 32247 -0157 |
| Contact | Denise E Mceachern |
| Correspondent | Denise E Mceachern VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. P.O. BOX 10157 Jacksonville, FL 32247 -0157 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-18 |
| Decision Date | 1996-10-01 |
| Summary: | summary |