The following data is part of a premarket notification filed by Vistakon, Johnson & Johnson Vision Products, Inc. with the FDA for Vistakon Multifocal (etafilcon A) Contact Lens.
| Device ID | K953804 |
| 510k Number | K953804 |
| Device Name: | VISTAKON MULTIFOCAL (ETAFILCON A) CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. 4500 SALISBURY ROAD, STE.300 Jacksonville, FL 32216 |
| Contact | Denise E Mceachern |
| Correspondent | Denise E Mceachern VISTAKON, JOHNSON & JOHNSON VISION PRODUCTS, INC. 4500 SALISBURY ROAD, STE.300 Jacksonville, FL 32216 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-08 |
| Decision Date | 1995-09-26 |